International Edition - 2014

CONVENTION ISSUE:

International Federation for the Surgery of Obesity & Metabolic Disorders

The Independent Newspaper for the General Surgeon

INTERNATIONAL EDITION

Volume 2 • Number 2 • 2014 GENERALSURGERYNEWS.COM

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Physician Stresses Simulation To Avert Harm to Real Patients

Finding Keys to Recovery After Colorectal Surgery

Physicians Should Be Selected on Skills Outside of Cognition B Y C HRISTINA F RANGOU

‘Small Bites’ Drop Rate of Incisional Hernias Multicenter, Randomized Trial Shows Significant Improvement

B Y V ICTORIA S TERN SALT LAKE CITYY—As a young combat pilot in the Israeli Air Force, Amitai Ziv practiced on a simulator for every nightmare scenario his trainers could come up with: ejecting from airplanes, landing planes overcome with flames, managing all sorts of equipment malfunctions.

When he started medical school after leaving the air force, he was astonished that medical trainees honed their skills not on simulators, but on real patients.

“We expect both health care and aviation to have very low tolerance for errors. But in health care, we are very much behind aviation in that respect,” Dr. Ziv said in a lecture at the 2014 Society of American Gastrointestinal

T

he goal of any perioperative protocol is to improve patient outcomes after surgery. In colorectal surgery, however, there is minimal evidence to support traditional perioperative practices, such as bowel preparation and fasting before surgery.

In the mid-1990s, this gap in understanding prompted a group of surgeons, led by Henrik Kehlet, MD, PhD, from Copenhagen, to begin implementing early recovery efforts. Following Dr. Kehlet’s work, a multinational group of surgeons and anesthesiologists began collaborating as the Enhanced Recovery after Surgery (ERAS) research group.

The aim of ERAS is to systematically study patients’ physiologic responses to surgery and develop a multifaceted, evidence-based approach to patient care in colorectal surgery and other disciplines.

At the 22nd International Congress of the European Association for Endoscopic Surgery (EAES), Nader Francis, MBChB, PhD, and colleagues presented an up-to-date review of ERAS in colorectal surgery, pinpointing factors that may allow surgeons to enhance and ultimately predict patient outcomes (abstract O074).

“There are many features that impact patient outcomes and we don’t necessarily know which are the most relevant to recovery,” said Dr. Francis, consultant

B Y C HRISTINA F RANGOU

Amitai Ziv, MD, believes personality traits should be considered more strongly when evaluating medical students and physicians. see SIMULATORS page 14

International Panel Forges Consensus on Early Rectal Cancer B Y V ICTORIA S TERN

O

ver the past 15 years, the treatment of rectal cancer has improved significantly with the emergence of new surgical techniques and technologies and as physicians have gained a greater understanding of disease pathology.

Despite such improvements,

see RECOVERY page 16

considerable variation exists in how experts manage early rectal cancer.

That is why Mario Morino, MD, M.Hon.AFC, chairman and director of Digestive and Minimal Invasive Surgery at University of Turin School of Medicine, Torino, Italy, and

INSIDE In the News

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Panel of Surgeons Says ’No’ to Noncompliant Hernia Patients

Stitches

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On the Spot

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The First Experts Discuss and Surgeon Nobel Debate the Use of Prize Winner: the Surgical Robot Emil Theodor Kocher, MD

see RECTAL CANCER page 16

LAS VEGAS—Surgeons can reduce a patient’s risk for developing an incisional hernia after laparotomy by as much as 35% if they use a “small bites” technique to close the fascia, a large randomized trial has shown.

“After this trial, we now recommend suturing the fascia of an abdominal midline incision with a continuous small-bite technique. This merits wide application,” said study co-author Eva Deerenberg, enberg, MD, a surgeon at Erasmus University Un Medical Center in Rotterdam, The Netherlands.

She presented the study results at the 2014 Annual Hernia Repair Meeting.

The STITCH trial was a multicenter, double-blind randomized controlled trial (RCT) designed to evaluate the effect of small stitches on long-term development of incisional hernia after midline laparotomy.

In recent years, support has grown see STITCH page 23

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / AUGUST 2014

New App Predicts Complications, Costs of Ventral Hernia Repair Tool May Allow for a More Informed Preoperative Discussion With Patients B Y C HRISTINA F RANGOU LAS VEGAS—It’s one of the oldest rituals between a surgeon and his or her patient: a preoperative discussion about a patient’s upcoming surgery. Now, there’s an app for that.

Hernia surgeons at Carolinas Medical Center have created an app that calculates a patient’s risk for postoperative wound complications and the associated costs from a ventral hernia repair.

“We can use this app to talk to our patients directly. We can show them how they are impacting their own outcomes,” said B. Todd Heniford, MD, director of the Carolinas Hernia Center, Charlotte, N.C., after announcing the app at the 2014 Annual Hernia Repair meeting.

The CeDAR app, short for the Carolinas Equation for Determining Associated Risks, predicts a patient’s risk for wound-related problems following ventral hernia repair.

The free app is intended for use by surgeons, patients or family members. Users answer eight questions about the patient, such as his or her height and weight, body mass index, smoking status and previous hernia repairs. Using the answers, the app calculates a percentage chance that the patient will develop postoperative complications requiring treatment.

The mathematical formula used to calculate the risk percentage is based on data from thousands of hernia patients around the world who are registered with the International

Hernia Mesh Registry. More than 1 million data points were used to create the formula, Dr. Heniford said.

Statisticians then confirmed the app’s accuracy and reliability.

CeDAR also provides an estimation of the corresponding cost of treatment.

Previous research from Carolinas Hernia Center has shown that the cost of a mesh infection after ventral hernia repair can reach six figures for a single patient’s care in the year after surgery. A patient who develops a mesh infection after surgery will incur inpatient hospital charges of $44,000 plus an additional $63,400 in follow-up costs over the next year, according to the analysis. Total expenses associated with a mesh infection can run as high as $107,000.

’When you use the data, you really can have an honest conversation with your patient.’

—William W. Hope, MD CeDAR is the second herniarelated app from the hernia team at Carolinas Medical Center. In 2012, the researchers released an app that predicts a patient’s risk for chronic discomfort one year after inguinal hernia repair.

William W. Hope, MD, assistant professor of surgery at the University of North Carolina, Wilmington, uses the inguinal hernia app frequently in his discussions with patients.

“It really opened my eyes. Before, I would tell a patient that you may have some chronic groin pain, but was quite surprised when I’d put their numbers in the app and

it would say a 15% to 20% risk for chronic pain. When you use the data, you really can have an honest conversation with your patient.

“It’s an exciting use of technology and an exciting way to try to predict outcomes,” he said.

Dr. Hope said he expects the ventral hernia app will encourage patients take a bigger role in their health care. “We can show them the difference it will make if they lose 20 pounds or if they quit smoking. They’ll see a difference in infection and the massive amount of money that can be saved.”

Surgeons also can use the app in discussions with health insurance companies, Dr. Heniford said.

In North Carolina, insurance companies are putting pressure on surgeons to prove that they offer high-quality care without additional costs.

Two private health insurance companies, representing 95% of privately insured patients in the state, now tier surgeons based on their clinical quality outcomes, cost efficiency and accessibility. Patients must pay extra to receive treatment from a specialist not listed in the best tier.

But it’s not always clear to patients or insurance companies that some surgeons accrue higher outcomes and costs because they treat a higher-risk population, Dr. Heniford noted.

“We can use this app to speak to insurance companies. If an insurance company says, ‘Doctor, you’re a bad surgeon,’ you can demonstrate to them the kind of patients you are operating on.”

Dr. Heniford announced the app during a presentation on “big data” and its growing role in health care.

Big data is a valuable health care tool that can be used to identify trends and correlations, to improve outcomes and to track surgeons’ performance, he said.

Surgeons need to take the lead on collecting their data to accurately reflect their patient population and their outcomes, Dr. Heniford said.

“If you as a surgeon have no data, [then] you have no fight against insurance companies.”

Surgeon-driven registries are taking off in hernia repair, he said. The International Hernia Mesh Registry started in 2007, and now includes data from more than 1,265 patients over a five-year period. More recently, American surgeons launched the Americas Hernia Society Quality Collaborative, which provides real-time outcomes data for surgeons.

Gastrectomy for Chronic Leak After Lap Sleeve Gastrectomy A lmino Ramos, MD, from Brazil, discussed the management of leak after laparoscopic sleeve gastrectomy (LSG) at the 2014 Surgery of the Foregut Symposium, Coral Gables, Florida.

Laparoscopic sleeve gastrectomy has increased exponentially over the past decade. Chronic leak after LSG remains a challenging complication to manage for most bariatric surgeons. Dr. Ramos discussed the management of chronic leak and shared some of his experiences with performing gastrectomy for resistant cases.

Sleeve gastrectomy creates a perfect storm for development of a fistula at the angle of His. Physiologic obstruction due to the pylorus and mechanical obstruction from the “L” shape of the sleeve causes increased pressure inside the sleeve. The negative pressure inside the thorax compounds this process.

Complete resection of the angle of His is desirable to achieve maximum weight loss. However, this might cause a leak due to the loss of blood supply in the surrounding area, leading to ischemic changes.

Initial management of leak at the angle of His remains nasoenteral feeding and drainage. Stent placement by endoscopy is one of the conventional methods used for fistula treatment. However, the anatomic position of the angle of His poses a challenge. Endoscopy has also been used for fibrin glue, mesh placement or clips. Some surgeons have proposed conversion of the sleeve into a Roux-en-Y gastric bypass.

Dr. Ramos discussed his experience with performing laparoscopic total gastrectomy for resistant cases of leak in

12 patients who already had at least one attempt with conventional treatment. Dr. Ramos concluded that, in his experience, laparoscopic total gastrectomy could be the only alternative in some cases of resistant leak and can be performed safely. These patients should wait at least three months and should initially undergo conventional methods of leak management. Surgeons should consider this procedure only after they have acquired substantial experience in bariatric and minimally invasive surgery procedures.

—Mayank Roy, MD

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / AUGUST 2014

U.S. Panel of Surgeons Says ‘No’ to Noncompliant Hernia Patients B Y C HRISTINA F RANGOU LAS VEGAS—Expert hernia surgeons are asking patients to adhere to strict preoperative regimens that include weight loss, smoking cessation and nutritional supplementation before surgery.

If patients fail to comply, surgeons say they will not operate or will postpone surgery, contending that the risks for infection or failure are too high.

“I make a deal with patients: When we go to the operating room, I will be an A plus and you will be an A plus. That’s just non-negotiable. If they want to meet those goals, then we talk about surgery,” said Michael Rosen, MD, a hernia surgeon and professor of surgery at Case Western Reserve University, in Cleveland.

Dr. Rosen was one of a group of hernia surgeons who spoke at a panel session during the 2014 Annual Meeting of the Americas Hernia Society (AHS). All six panelists said they have adopted preoperative protocols that require patients to comply with various steps before surgery.

When Dr. Rosen meets with a patient for the first time, he limits the conversation to a discussion of the patient’s smoking habits and obesity.

“We don’t talk about the operating room. We don’t talk about any of that. Without those two things, you

don’t get to go to the next step.

It is a practice that falls into a ‘If we can get the patient We talk about goals. We achieve longstanding controversy in general optimized, we will wait to surgery: Is a surgeon ethically oblithose goals. It’s simple to me.”

He sees the patient again three get them optimized. That’s gated to operate on a noncompliant months later. Then, provided the patient? one thing people miss— patient has quit smoking and In January, when Frederick lost the recommended amount just because you can do Greene, MD, General Surgery News’ of weight, he will discuss surgichief medical advisor, suggested that a component separation, surgeons “take a hard line, especal options.

Not all surgeons focus on the doesn’t mean you should cially for elective operations” with same processes, although most patients who refuse to quit smoking [do it] right away.’ gave high priority to weight loss [page 1], several readers criticized and smoking cessation. the approach. One called this argu—Parag Bhanot, MD “We have protocols in place, ment “deeply repugnant.” But others particularly pertaining to smokagreed, saying surgeons must coning and achieving optimal weight losss sider many factors before taking a patient si before proceeding to surgery,” said Bren nt too the operating room: notably, the risk for D. Matthews, MD, AHS president an and posstoperative complications or the need for professor of surgery and chief of min nireooperations. mally invasive surgery, Washington Un niHernia surgeons contend that, particuH versity School of Medicine, St. Louis. larly for abdominal wall reconstructions, la “We have a whole series of protocolss the risks associated with doing surgery outfor patients,” said Robert Martindale, weigh the benefits in patients who continue MD, PhD, professor of surgery and chief of general eral sur- to smoke sm or fail to lose excess weight. gery at Oregon Health & Science University, Portland.

“If we can get the patient optimized, we will wait to “We don’t use all of them on everybody. We priori- get them optimized. That’s one thing people miss—just see PREOPERATIVE REGIMEN page 15 tize them.”

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Stitches

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / AUGUST 2014

The First Surgeon Nobel Prize Winner: Emil Theodor Kocher, MD Groundbreaking Work in the Field of Thyroid Surgery B Y V ICTORIA S TERN

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n 1909, Emil Theodor Kocher, MD, was awarded the Nobel Prize in Physiology or Medicine for his contributions to physiology, pathology and surgery of the thyroid. Dr. Kocher was the first surgeon ever to receive this honor.

Although the Nobel Prize was his greatest award, it was far from his only one.

During his lifetime, Dr. Kocher was given 35 honorary memberships to societies all over the world, the first of which was the Medical Society of London, in 1889.

Dr. Kocher’s drive for recognition, consuming quest for knowledge and precise operative technique made him stand out among his peers and helped propel him to fame.

“Dr. Kocher certainly wanted to achieve something,” said Ulrich Tröhler, MD, PhD, former director of the Institute for the History of Medicine at the University of Freiburg, and author of a book-length biography of Dr. Kocher. “He was persistent, diligent and single-minded when it came to surgery.”

Dr. Kocher was born in Bern, Switzerland, on Aug. 25, 1841, to Jakob Alexander Kocher and Maria Kocher. His father, an industrious railway engineer, and his deeply religious mother had profound influences on the man he became.

A precocious and ambitious child, Dr. Kocher excelled in school and by age 17, chose to study medicine at the University of Bern. Shortly after graduating summa cum laude, he toured medical institutions in Germany, England and France in order to rub elbows with some of the surgical legends of his day. For instance, while in London, he visited Sir Thomas Spencer Wells, who had designed hemostatic clamps and forceps to control bleeding during surgery and developed a hygienic method of surgery.

“Dr. Kocher was impressed that Dr. Wells operated so cleanly,” Dr. Tröhler said. “He washed his hands and instruments, which is the reason he operated with such success. In contrast, Dr. Kocher was disgusted by surgeons in Paris, who operated in filthy conditions, wearing aprons clotted with blood.”

After his travels, Dr. Kocher worked as the assistant of George Albert Lücke, MD, full professor of surgery and chair at the University of Bern. In 1869, he married Marie Witschi-Courant, a pious woman with whom he had three sons.

In 1872, at only 31 years old, Dr. Kocher became professor of clinical surgery at the University of Bern, a position

he kept for the next 45 years.

That same year, he performed his first thyroidectomy. At the time, thyroid surgery was considered extremely dangerous, with some estimates putting the mortality rate as high as 75% (Acta ( Otorhinolaryngol Ital 2009;29:289). Dr. Kocher wrote to Joseph Lister, who in 1867 had pioneered the anti- Emil Theodor Kocher, MD septic treatment of wounds, Photo courtesy of Wikipedia

in order to reinstitute the technique in his clinic (it had been abandoned because of cost). This was an important move that helped elevate Dr. Kocher’s clinic to a leading surgical center.

Dr. Kocher became known, in particular, for enhancing the safety of thyroid surgery by

developing his own technique that combined the use of general anesthesia, antisepsis and hemostasis. He developed instruments called Kocher clamps (which he essentially copied from Dr. Wells), but perhaps most notably, in his quest to perfect thyroid surgery, he introduced a precise, slow technique that allowed him to avoid infection and selectively remove all diseased thyroid tissue, or in some cases, the entire gland. Over the next few see NOBEL PRIZE page 6

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Fastest Cutting with Best-in-Class Vessel Sealing from a Single Instrument

To contact an Olympus representative call 800-848-9024 or visit www.medical.olympusamerica.com/gsur © 2014 Olympus America Inc. Trademark or registered Trademark of Olympus and its affiliated entities in the U.S. and/or other countries of the world. All patents apply. OAIURO0414AD12969

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Stitches NOBEL PRIZE

jContinued from page 5 decades, he performed more than 6,000 thyroid operations and reduced the mortality rate of the procedure to less than 0.5% (J ( Clin Neuroscii 2009;16:1552-1554).

“His slow and careful operating style astonished visitors from all over the world,” Dr. Tröhler said. He became a sought-after surgeon. Wealthy people throughout Europe, as well as Russian and Polish nobility, traveled to see Dr. Kocher. Even politician Vladimir Lenin brought his wife to Bern for an operation.

Dr. Kocher’s profound volume of operations was possible, in part, because he operated simultaneously on two tables.

After enucleating the goiter, Dr. Kocher would operate on a patient on an adjacent table while his eldest son, Albert, also a surgeon, was left to close the wounds.

“This was a painstaking process for his son, who had to remove 20 to 30 Kocher clamps and tie off each vessel by hand,” Dr. Tröhler said.

In 1883, Dr. Kocher’s obsessiveness brought him close to unraveling a medical mystery that had baffled researchers for decades. His efforts to do so highlight one of his most influential cases, which ultimately changed the way researchers investigate and analyze patient outcomes.

By the late 1800s, some surgeons had been performing thyroid surgery for goiter, but no one yet understood how the gland worked. Several experts expressed suspicions that damage to the thyroid might cause hypothyroidism, known then as myxedema (Trans Clin Soc Lond 1874;7:180-185), while others, including Dr. Kocher, thought that the thyroid gland had no function at all.

On the subject, Dr. Kocher wrote: “Unfortunately the physiologists know next to nothing about the physiological significance of the thyroid gland, and this may have been the main reason for surgeons tacitly assuming that the thyroid gland had no function at all” (Archiv ( für Klinische Chirurgiee 1883;29:254-337).

In 1874, Dr. Kocher removed the thyroid of an 11-year-old girl, Maria Bichsel. Six months after the operation, Ms. Bichsel’s physician, August Fetscherin, MD, contacted Dr. Kocher to inform him that the girl had changed dramatically after surgery (Schweiz Med Wochenschrr 1970;100:721-727). In a letter to Dr. Kocher, Dr. Fetscherin wrote that she had always been a lively and intelligent girl, but had now become overweight and lazy. At the time, Dr. Kocher did not heed these comments. “He didn’t care, he was just interested in improving his operative technique,” Dr. Tröhler said.

It wasn’t until eight years later, in 1882, while attending an international meeting in Geneva, that Dr. Kocher realized the significance of Dr. Fetscherin’s remarks.

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / AUGUST 2014

During a conversation, his colleague Jacques Louis Reverdin asked Dr. Kocher if he had noticed certain symptoms in patients who had had their entire thyroid removed, specifically delays in physical and intellectual development (Revue Médicale de la Suisse Romandee 1883;3:169198, 233-278, 309-364).

The inquiry prompted Dr. Kocher to reconsider what Dr. Fetscherin had reported years earlier. He tracked down Ms. Bichsel, and found that the girl had indeed undergone a striking transformation. Once mistaken for her younger sister, she was now physically stunted and

True to his nature, Dr. Kocher was working almost right up until his death, performing his last surgery just four days before he passed away on July 27, 1917, at the age of 76. her extremities and body had swelled. Dr. Kocher noted that she exhibited impaired cognitive function, writing that she “exhibits the ugly looks of a semi-idiot.”

In February 1883, Dr. Kocher invited

77 of 102 of his former thyroidectomy patients for a follow-up. He was only able to reexamine 34 patients but received written reports from 26 patients. The 28 patients who had undergone partial thyroidectomies were in good health, but the 34 with total thyroidectomies had not fared so well; five had died, one had thyroid cancer, and 16 of the 18 whom Dr. Kocher reexamined in person exhibited distinct mental and physical deterioration.

Dr. Kocher now understood that the thyroid’s function was essential. In an 1883 lecture to the German Congress of Surgery, Dr. Kocher defined a new

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Stitches

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / AUGUST 2014

Despite the negative reactions, Dr. Kocher propelled his research forward. His first step was to declare that he would never again perform total thyroidectomies ... He always left a small piece of thyroid tissue intact. disease called “cachexia strumipriva” (or severe hypothyroidism, in modern terminology), caused by removing the whole thyroid ((Archiv für Klinische Chirurgie 1883;29:254-337). Dr. Kocher went on to describe his meticulous methods to unravel the effects of completely removing the thyroid, publishing his copious

patient records along with notes from 134 additional cases performed by colleagues.

He concluded by discussing several theories about the thyroid’s role in the body, including his own erroneous hypothesis that the gland regulated blood flow to the brain as well as respiration.

Dr. Kocher’s careful investigation of

former patients represented an early example of a follow-up study, and his focus on thorough scientific documentation and analysis marked an important legacy of his work.

Reactions to his lecture were mixed, however. Although some colleagues praised Dr. Kocher for his innovative ideas, most criticized him for his operative lust. Critics also stated that cachexia strumipriva was not a new condition, but rather represented the late stages of cretinism, which had been defined earlier by Sir William Gull and others.

Dr. Kocher had indeed failed to

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acknowledge the contributions of his colleagues, Dr. Tröhler noted, behavior that became a pattern for him. Even in his Nobel Prize acceptance speech, he did not give Dr. J.L. Reverdin credit for being the first to discover that removing the entire thyroid causes severe physical and mental damage ((J Royal Soc Med 2011;104:129-132).

Despite the negative reactions, Dr. Kocher propelled his research forward.

His first step was to declare that he would never again perform total thyroidectomies. In future cases, he always left a small piece of thyroid tissue intact.

“He realized what he had done, and being a deeply religious man, felt that he had sinned,” Dr. Tröhler said. “This desire to repent for his sin motivated him to try to rectify his error by performing the first organ transplant.”

By July 1883, Dr. Kocher began transplanting thyroid tissue, first under the skin, then locally and finally into the bone marrow of patients who had undergone total thyroidectomies, hoping to reverse the adverse effects of the surgery.

Dr. Kocher often operated on two tables simultaneously so that he could take fresh thyroid from one patient and transplant it into the other. He also prescribed fresh thyroid sandwiches, and later tablets of dried thyroid for patients to consume.

“Dr. Kocher saw some transient improvements when transplanting pieces of organs, but basic science was not developed enough at the time for him to understand the immune reactions that might occur,” Dr. Tröhler said. “In fact, it’s incredible that patients survived these transplants. This speaks to Dr. Kocher’s excellent operative technique.”

Dr. Kocher’s endeavors in thyroid transplantation became a prototype for future organ transplants and a jumpingoff point for research on transplantation.

Although best known for his work on the thyroid, Dr. Kocher’s interests also extended to neurosurgery, cancer surgery and abdominal surgery. Dr. Kocher performed one of the earliest cholecystectomies, devised a technique to reduce a dislocated shoulder, and developed his famous Kocher clamp. Dr. Kocher also conducted extensive research on wound ballistics to treat battle wounds and infections (Surg Gyn Obstett 1991;172:153-160).

True to his nature, Dr. Kocher was working almost right up until his death, performing his last surgery just four days before he passed away on July 27, 1917, at the age of 76.

On his personality and skill, Dr. Tröhler said, “Dr. Kocher was only interested in surgery. He developed a carefulness in operating, which we might call a physiologic style. This was quite extraordinary in his time, set new standards and is in some sense still with us today.”

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Welcome to the July issue of The Surgeons’ Lounge. In this issue, we welcome our readers to respond to the case presented, and be featured as our next “guest expert”! Send your replies to me at szomsts@ccf.org before Sept. 10, 2014. Please do not forget to include your full name and affiliations to ensure you are listed correctly.

Check out the special “Double Express” and see how the experts answer the following questions: “What is the smallest incisional hernia you will not perform laparoscopically?” and “Do you leave any drains after large openincisional hernia repair with prosthetic mesh?”

Feedback from our readers is our greatest asset. Tell us how we’re doing! What do you want to see more of? Less of? What is the best part of Surgeons’ Lounge? What can we do even better? We look forward to your feedback!

Sincerely, Samuel Szomstein, MD, FACS Editor, The Surgeons’ Lounge Szomsts@ccf.org

Dr. Szomstein n is associate director, Bariatric Institute, Section of Minimally Invasive Surgery, Department of General and Vascular Surgery, Cleveland Clinic Florida, Weston.

Question for Our Readers Amir Mehran, MD University Bariatrics, Thousand Oaks, Calif., and Ara Keshishian, MD, Central Valley Bariatrics, Verdugo Hills, Calif.

A 65-year-old man presented with a painful enlarging symptomatic umbilical hernia that he had for several years.

He denied any obstructive gastrointestinal (GI) symptoms or coughing, urinary hesitancy or constipation. His past history was significant for obesity, hypertension, sleep apnea, gastroesophageal reflux disease, mild lower extremity edema and an open appendectomy. He did not use tobacco and took Olmesartan and close to a dozen herbal and naturopathic supplements. Physical examination revealed a body mass index of 34 kg/m2, and a partially reducible umbilical hernia measuring roughly 5 cm in diameter. Mild skin “stretch” discoloration was also noted without any obvious cellulitis.

After a thorough discussion of his options, a decision was made to proceed with a laparoscopic repair with mesh due to his obesity and to avoid going through the discolored area.

After a thorough medical evaluation, he underwent an uneventful laparoscopic

umbilical hernia repair with a 15 x 20 cm Physiomesh (Ethicon EndoSurgery). The patient had received a 900mg IV preoperative dose of clindamycin (anaphylactic penicillin allergy) and the mesh had been soaked in antibioticlaced saline solution.

Two 5-mm ports and a 12-mm port, all nonbladed, were placed along the left abdomen. The hernia contained omentum, which was dissected off using gentle traction and the Harmonic Scalpel (Ethicon EndoSurgery). Using the Securestrap fixation device (Ethicon EndoSurgery), the umbilicus was everted by tacking the hernia sac inside the abdomen, thus giving the patient a normal looking umbilicus (“innie”). The mesh was inserted through the 12-mm port and did not come into contact with the skin at any point. It was secured with four preplaced Gore CV-0 transabdominal fixation sutures (WL Gore), as well as two rows of Securestrap tackers. Diagnostic laparoscopy at the end of the case did not reveal any intraabdominal injuries or bleeding. The Foley catheter, placed at the beginning of the case, was removed without sequelae. The patient tolerated the procedure well and was discharged the same day at his request, once he was able to tolerate

fluids and void on his own. He was not discharged on any antibiotics.

The patient did well for the next two weeks but then called about a low-grade fever (100.1 F) associated with coughing, hoarseness and left lower abdominal pain near the left iliac crest. He denied any GI symptoms, pain or redness around the incisions. Due to the driving distance involved, he opted to see his primary care physician (PCP) first. His PCP performed routine laboratory tests and diagnosed him with an upper respiratory infection and possible laryngitis.

The patient was seen in the surgical clinic five days later and was noted to have painless erythema around the umbilicus (Figure 1). His abdominal exam was otherwise unremarkable, including recurrence or seroma formation. On further questioning, however, the patient did complain of a new onset of urinary hesitancy and tenesmus.

Because he had never undergone a colonoscopy or annual urologic exam, a rectal examination was performed revealing a large hard prostate and extreme discomfort. The erythema boundaries were marked and the patient was discharged on oral clindamycin. The patient’s PCP subsequently

Figure 1. Day of reoperative surgery. changed the antibiotics to nitrofurantoin because the lab work from five days before showed an Escherichia colii urinary tract infection with elevated serum white blood cell (WBC) count. Of note, the patient’s preoperative WBC was normal and a urinalysis was not performed because he was asymptomatic.

When the patient was contacted a few days later, he reported worsening fever, lethargy and no change in the abdominal wall erythema. He was advised to present to the emergency room where the examination revealed a temperature of 101.9 F, a pulse of

Surgeons’ Lounge

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / AUGUST 2014

visits, the patient remains well and does not wish any further herniorrhaphy.

Figure 2. Intraoperative picture of inferior aspect of mesh.

123 beats per minute, persistent periumbilical erythema with warmth, but no abdominal distention or any tenderness to palpation. Laboratory work was significant for a WBC count of 24,000 with left shift and a urinalysis with positive leukocyte esterase, significant pyuria and moderate bacteria. A contrast abdominal computed tomography was performed, demonstrating a prominent prostate, bladder wall thickening and some nonspecific fluid around the mesh and hernia site. The patient was admitted to the hospital and upon consultation with infectious disease consultants, was placed on vancomycin, levofloxacin and metronidazole.

The patient did not clinically improve over the next 24 hours and the erythema appeared to have worsened. He was taken to the operating room for a laparoscopic exploration and possible mesh removal. Intraoperatively, the superior aspect of the mesh was found to be clean with minor omental adhesions.

The inferior aspect, however, had thicker adhesions with a pocket of fibrinous fluid (Figure 2). Using the Harmonic Scalpel, the mesh was fully excised and removed with an endobag. Gram stain of the mesh revealed no organisms with rare PMNs [polymorphonuclear leukocytes].

The patient made a very rapid recovery and was discharged from the hospital within 48 hours on oral antibiotics pending outpatient evaluation and final mesh culture results, which remained negative. Final pathologic examination of the specimen showed adherent fibro adipose tissue with fibrosis, fibrin deposition, foreign body reaction and mostly chronic inflammation. In follow-up

Questions: • Is this case consistent with mesh allergy or mesh infection and what are alternative management options?

• If this was an allergic reaction, is this the typical course and is this particular mesh (or any other mesh) known for this type of reaction? Is there any rationale for prescribing corticosteroids before reoperative surgery?

• If this was due to a urinary tract infection, is it likely from a Foley or from prostatitis or both, and is this the course normal (i.e., two weeks postoperatively? No pain and no microbes on path or cultures?)?

• Should the urinalysis be checked on all patients including asymptomatic men and is there a role for continued antibiotics (IV or oral) after surgery?

continued ON page 10

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Surgeons’ Lounge Expertess Expr

Double

Q.

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / AUGUST 2014

Edward Felix, MD: Small umbilical or tiny midline congenital hernias.

Incisional usually laparoscopic.

What is the smallest incisional hernia you will not perform laparoscopically?

Natan Zundel, MD: 3 cm

Michael Sarr, MD: 3 cm

you leave any drains after Q.Dolarge open-incisional hernia repair with prosthetic mesh?

David Edelman, MD: 2 cm, but it’s not the size, it’s the symptoms and whether it’s recurrent.

Edward Lin, MD: 3 cm

Yes Ronald A. Hinder, MD: 3 cm

Nataniel Soper, MD: 3 cm

Maher Abbas, MD: 2 cm, 3 cm or ggreater, consider laparoscopy, because ssometimes smaller defects can be sseen around the hernia site.

Edward H. Phillips, MD: I prefer oopen-incisional hernia repair except ssubxyphoid hernias. Usually the whole wound will eventually deteriorate and w rrecurrences are at the edge of limited rrepairs. So size doesn’t matter, but for sure any ventral incisional hernia I can repair under local monitored anesthesia care, I will do “open.”

Dan Herron, MD: 2 cm

Edward H. Phillips, MD Raul Rosenthal, MD Michael Sarr, MD Edward Felix, MD Nataniel Soper, MD David Edelman, MD

No Natan Zundel, MD Edward Lin, MD Daniel M. Herron, MD Maher Abbas, MD Ronald A. Hinder, MD

Cryoablation Obviates Need for Surgery in Select Group of Patients M ONICA J. S MITH LAS VEGAS—For a selected group of women with early-stage invasive ductal cancer (IDC), cryoablation appears to be so effective that they may never need to enter the operating room, according to the research presented at the 2014 American Society of Breast Surgeons annual meeting.

To evaluate the procedure, lead author Rache Simmons, MD, chief of breast surgery, NewYork-Presbyterian/Weill Cornell Medical College, New York City, and colleagues from 19 different treatment centers conducted cryoablation procedures on 86 women with unifocal IDC 2 cm or smaller.

The approximately 20-minute procedure consisted of the insertion of an ultrasound-guided cryoprobe to the targeted lesion, with a freeze/thaw cycle of 6-10-6 minutes or 8-10-8 minutes. After ablation, the tumors were removed for pathologic confirmation of the treatment’s success.

“We were looking for the success of the ablation, which we defined in two ways,” Dr. Simmons said. One definition was the

lack of residual infiltrating cancer or ductal carcinoma in situ (DCIS), and the second was the lack of residual invasive cancers; the procedure would still be considered a success if the patient had DCIS. By the first definition, cryoablation was successful in 60 of the 87 patients (69%); by the second definition, it was successful in 70 (81%).

“Then we broke the patients down by tumor size, which showed to be quite important,” Dr. Simmons said. The procedure was successful, with no invasive or in situ disease, in 63% of patients with tumors 1 cm or larger. But patients with tumors smaller than 1 cm had 94% ablation, which was considered remarkable, and was statistically significant (P=0.018).

P A secondary objective of the study was to evaluate the negative predictive value of postablation magnetic resonance imaging (MRI).

“The reason we designed the study this way is that we didn’t expect to have 100% success, and we were hoping that MRI after ablation would be able to tell us how successful we were,” Dr. Simmons said. If so, “in a future nonresection trial, [MRI] could be deemed a surrogate for pathology so we would know if these patients

have residual disease.” breast cancer,” said Deanna J. Attai, MD, The MRI findings turned out to be assistant clinical professor, Department of consistent with the subsequent pathology Surgery, David Geffen School of Medireports in 86% of the patients who were cine, University of California Los Angenegative for IDC and 75% of those who les, who was an investigator on the study. were negative for both IDC and DCIS, “This important study helps advance suggesting that MRI may indeed be able nonsurgical tumor ablation as an importo predict pathology findings. tant option for women with small ultraLooking at the overall data, complete sound-visible breast cancers,” said Shelablation was attained in 69% of the patients, and ‘I think it’s incredible that we’ve gone when success was defined as from radical mastectomies ... to the complete ablation or residual disease detectable on promise of nonsurgical therapy for MRI, the procedure was selected patients with breast cancer.’ considered successful in —Deanna J. Attai, MD 76% of the cases.

“But what’s really important was when we broke this down by size don Marc Feldman, MD, FACS, chief, we found that 94% of all tumors less than Division of Breast Surgery, Vivian L. 1 cm had complete ablation. We also con- Milstein Associate Professor of Clinical sidered it a success if we saw the residual Surgery, Columbia University College of tumor on MRI, we had 100% success in Physicians and Surgeons, New York City. those less than 1 cm,” Dr. Simmons said.

“I anticipate that with improvements in “From my standpoint as a surgeon, I ablation technology and breast imaging think it’s incredible that we’ve gone from that breast cancer tumor ablation will radical mastectomies, which were still have an important role in patient care,” he being done occasionally when I was a added. “Patients are very eager to pursue medical student, to the promise of non- ablation as an alternative to open surgical therapy for selected patients with surgery.”

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History of Lap Colectomy: An Approach Still Awaiting Widespread Use B Y V ICTORIA S TERN

I

n October 1990, an elderly woman came to see Dennis Fowler, MD. She had several critical issues, including severe lung disease and a tumor resting in the middle of her sigmoid colon.

Dr. Fowler, an assistant clinical professor of surgery at the University of Missouri, Kansas City School of Medicine at the time, sat with his patient and her son, discussing treatment options. Dr. Fowler was reluctant to perform surgery because of the woman’s obstructive lung disease.

The patient, however, kept insisting that she would rather die from an operation than leave the cancer inside her.

Dr. Fowler told her about a new technique that he and several colleagues had been investigating over the summer. It involved taking out a section of the colon laparoscopically. He had trialed the technique in the pig lab, but the procedure had never, to his knowledge, been attempted in a human patient.

“After numerous discussions, the patient said she wanted this new procedure,” Dr. Fowler said.

On Oct. 19, after receiving three prototypes of a laparoscopic intestinal stapler from U.S. Surgical, Dr. Fowler performed the first laparoscopic sigmoid colectomy. He used one stapler to ligate the mesentery and two to transect the colon intraperitoneally. He then created a small muscle-splitting incision in the left lower quadrant of the abdomen to remove the specimen and completed the anastomosis intracorporeally with a circular stapler.

Dr. Fowler was astonished by the patient’s progress. “Her recovery was amazing considering that she had such serious obstructive lung disease,” Dr. Fowler recalled. “I realized there might be a real benefit to having colon surgery performed laparoscopically.”

Laparoscopic Colectomy Beginnings As laparoscopic cholecystectomy gained popularity in the late 1980s, physicians started looking for the next home run for minimally invasive surgery (MIS).

“The way we started was very innocent,” said Miami-based general surgeon Moises Jacobs, MD, recollecting his first laparoscopic colectomy case in June 1990.

The patient had a particularly “floppy colon,” Dr. Jacobs recalled, and consequently he could mobilize everything using one small incision. Dr. Jacobs and colleagues Harold Goldstein, MD, and Juan Carlos Verdeja, MD, placed four trocars in the abdominal cavity and,

‘I didn’t just jump off a cliff without a parachute.

I took the idea to the lab, worked out issues, bounced ideas off colleagues, and consequently have had minimal problems.’

—Morris Franklin, MD

using cautery, mobilized the white line of Toldt and the hepatic flexure. Through a small incision in the right lower quadrant, they exteriorized the colon, completing the first laparoscopic-assisted right hemicolectomy. The woman went home four days after surgery.

“We knew there must be something to this new technique,” Dr. Jacobs said.

Dr. Jacobs’ foray into laparoscopy began with cholecystectomy. In December 1989, he and his colleagues began performing laparoscopic cholecystectomies using a two-handed approach.

“We were doing two-handed surgery from the very beginning, and as a result, it was easier for us to transition into more complex surgeries,” Dr. Jacobs said.

When Dr. Jacobs became interested in applying laparoscopic techniques to colon surgery, he worked intensively in the pig lab to hone his skills until completing his first laparoscopic colectomy in June 1990.

After this success, Dr. Jacobs began investigating a variety of techniques for laparoscopic colon surgery with colleagues, including Dr. Verdeja and colorectal surgeon Gustavo Plasencia, MD (Arch ( Surg 1994;129:206-212; Dis Colon Rectum 1994;37:829-833).

“These surgeons knew this was going to be the next big deal,” said Morris Franklin, MD, director of the Texas Endosurgery Institute. “They made significant contributions early on when it really counted.”

Halfway across the country in San Antonio, Dr. Franklin was also exploring laparoscopic surgery. In 1988, Dr.

Franklin, alongside urologist William Schuessler, MD, and gynecologist Thierry Vancaillie, MD, started investigating laparoscopic pelvic lymph node dissection for prostate cancer, a demanding procedure they eventually mastered and began teaching to urologists worldwide.

Dr. Franklin saw laparoscopic cholecystectomy as a better teaching tool for laparoscopy. He and Dr. Schuessler began performing up to 15 cholecystectomies a day. They also received institutional review board approval from their hospital to explore new, more advanced laparoscopic techniques, and completed the first distal prostatectomy, splenectomy and one of the first hiatal hernia repairs.

Dr. Franklin soon developed an interest in colon surgery. He and his colleagues spent every weekend for 18 months in the pig lab and any additional free moments developing their skills.

In August 1990, Dr. Franklin performed his first laparoscopic colectomy. Several months later, in April 1991, he did the first completely laparoscopic right hemicolectomy.

“I tried to do it right,” Dr. Franklin said. “I didn’t just jump off a cliff without a parachute. I took the idea to the lab, worked out issues, bounced ideas off colleagues, and consequently have had minimal problems.”

Richard Whelan, MD, recalls Dr. Franklin’s unique abilities. “Dr. Franklin set the bar in the early days and he still does today,” said Dr. Whelan, professor of surgery and chief of surgical oncology at St. Luke’s-Roosevelt Hospital in New York City. “His skill set is

hard to match.”

Perhaps the first person to perform a laparoscopic colectomy was a gynecologist named David Redwine, MD, in the late 1980s, Dr. Franklin noted.

Several other general surgeons ventured into laparoscopic colon surgery early as well. In 1990, Garth Ballantyne, MD, started visiting U.S. Surgical on Tuesday afternoons to practice laparoscopic colectomies on pigs with fellow surgeon Patrick Leahy, MD. In late 1990, Dr. Leahy resected a proximal rectal cancer laparoscopically with the EndoGIA® (U.S. Surgical) and in February 1991, Dr. Ballantyne did his first laparoscopic colectomy at Yale University. Another general surgeon, Joseph Uddo, MD, performed an entirely laparoscopic right hemicolectomy in July 1991.

The Technique Spreads Dr. Fowler presented on his first laparoscopic sigmoid resection at the Society of American Gastrointestinal and Endoscopic Surgeons meeting in April 1991 (Surg Laparosc Endosc 1991;1:183-188).

“I had an overwhelming response from people all over the world,” Dr. Fowler said. “Not many surgeons knew what had been done, and were eager to engage in training programs to learn the procedure.”

As with laparoscopic cholecystectomy, interest in laparoscopic colectomy prompted surgeons to initiate weekend training courses. By November 1991, Dr. Ballantyne had organized courses for U.S. Surgical. Around that time,

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Ethicon had arranged laparoscopic colectomy workshops, run by Steven Wexner, MD, of Cleveland Clinic, Weston, Fla. The industry competitors invited many of the same faculty to their courses, and this core group of surgeons soon branched off into U.S. Surgical and Ethicon camps.

Several industry leaders, namely Lee Cohen, head of laparoscopic marketing and technology at U.S. Surgical in Norwalk, Conn., and Nicholas Valeriani, president of Ethicon Endo-Surgery for many years, supported and pushed the advancement of laparoscopic technology and education. “I often referred to Ms. Cohen as the queen of laparoscopy,” Dr. Ballantyne recalled.

On the global front, Dr. Franklin traveled to Australia, New Zealand and South America in the early 1990s to introduce laparoscopic colectomy to surgeons. Drs. Jacobs and Plasencia also taught some of the first international courses in laparoscopic colectomy.

“International surgeons, such as [Australians] Russell Stitz, MD, and Leslie Nathanson, MD, who went back home after these courses are now leaders in laparoscopic colorectal surgery,” said Dr. Franklin.

Even with training, however, many surgeons struggled to learn the new techniques. Dr. Ballantyne recalled surgeons’ ambivalence about laparoscopic colectomy. “When we surveyed the attendees [of the U.S. Surgical course], many said, ‘Thanks for a great course, Garth, but you’ve convinced me that laparoscopic colectomy is too hard to do and I’ll never do one.’”

Laparoscopic colectomy is not as easy as laparoscopic cholecystectomy largely because it involves navigating at least two, and often all four, quadrants of the abdomen.

“The majority of surgeons didn’t want to learn laparoscopic colectomy because it was much harder than open surgery,” Dr. Whelan said.

Laparoscopic colectomy was also different from laparoscopic cholecystectomy because patients didn’t demand that their colectomy be completed laparoscopically. “Surgeons, even now, don’t as often feel pressure from patients to do their colectomy laparoscopically,” Dr. Fowler said.

Dr. Jacobs noted that the low volume of laparoscopic colectomy cases by general surgeons in the United States made it harder for surgeons to gain experience.

“I think the low volume of cases slowed down the adoption of laparoscopic colectomy,” he said. But what almost halted its evolution was the concern over tumor recurrence.

Safety Concerns Halt Spread In 1994, worries about the safety of the

procedure emerged. A study by Berends et al in The Lancett reported that three of 14 patients (21%) undergoing laparoscopic colectomy had tumor recurrence at the trocar wound sites (1994;344:58).

Subsequent data have shown unambiguously that when the procedure is performed correctly, there is no increase in tumor recurrence at the incision.

“A surgeon can prevent a portsite recurrence simply by doing good, clean surgery,” said Dr. Franklin, who found that the quality of surgical technique directly influenced the incidence of port-site recurrences (Surg Endosc 2001;15:121-125). “After 3,500 cases, I haven’t had a single tumor implant at the trocar site.”

Before the study was ultimately published in 2004, a group of laparoscopic surgeons worked diligently to verify the safety of laparoscopic colectomy.

“Despite the resistance, we persisted,” Dr. Jacobs said. “My colleagues and I had been doing laparoscopic colectomy for four years already and didn’t have any bad results.”

In 1991, Dr. Jacobs and his colleagues completed a series of 20 laparoscopicassisted colon resections (Surg Laparosc Endoscc 1991;1:144-150), and independently, Dr. Franklin and his colleagues performed 51 laparoscopic colectomies ((Ann Surgg 1992;216:703-707). Both studies showed the technique was safe.

Several years later, Dr. Franklin pub-

‘I had an overwhelming response from people all over the world. Not many surgeons knew what had been done, and were eager to engage in training programs to learn the procedure.’

—Dennis Fowler, MD But even the suggestion that tumors implanted in laparoscopic incisions more often than in open incisions led some major academic institutions and colorectal societies to limit or even ban laparoscopic colectomies.

“At Columbia University, senior surgeons stopped us from doing laparoscopic surgery, and colorectal societies were against laparoscopy because of the lack of data,” said Dr. Whelan. “In addition, many older surgeons felt threatened and didn’t want to see any laparoscopic surgery.”

Surgeons who continued to perform laparoscopic colectomies experienced considerable backlash from the surgical community.

“Several of us were threatened by colleagues,” Dr. Fowler said. “Sometimes action was taken against us to reduce our privileges or turn patients against us.”

The resistance to laparoscopic colectomy reveals a lot about human nature, Dr. Jacobs said. “Some surgeons [who performed open surgery] didn’t want to lose patients and money to this new technique.”

It took 10 years before a definitive randomized controlled trial (RCT) created a large-scale shift in people’s thinking about laparoscopic colectomy (N Engl J Medd 2004;350:2050-2059). The COST [Clinical Outcomes of Surgical Therapy] trial, which began in 1994, involved 48 institutions and 872 patients with colon cancer randomly assigned to open or laparoscopic-assisted colectomy. Recurrence rates in surgical wounds were less than 1% in both groups, and the overall survival rate at three years was almost identical.

lished a five-year prospective randomized trial comparing open and laparoscopic approaches to colon cancer, and found the laparoscopic procedure offered similar oncologic resections and better recovery than open surgery (Dis Colon Rectum 1996;39:S35-S46).

In 1996, James Fleshman, MD, Anthony Senagore, MD, and Heidi Nelson, MD, reported retrospective data from the COST study, showing the same 1% rate of tumor recurrence at the wound sites in laparoscopic and open colectomy (Dis Colon Rectum 1996;39:S53-S58).

In 1998, Jeffrey Milsom, MD, from Cornell University, performed a prospective RCT comparing laparoscopic and open techniques in 109 patients undergoing bowel resection for colorectal cancers or polyps. Dr. Milsom showed an advantage in the laparoscopic group in terms of recovery time and return to bowel function, and found no port-site cancer recurrences in the laparoscopic group ((J Am Coll Surgg 1998;187:46-54).

That same year, Antonio M. de Lacy, MD, from Barcelona, also published a prospective randomized trial comparing laparoscopic-assisted and open colectomy for colon cancer, revealing similar results, and in 2002, published a follow-up showing a slight survival benefit in the laparoscopic group (Surg Endoscc 1998;12:1039-1042; Lancet 2002;359:2224-2229).

These studies not only confirmed that laparoscopic colectomy was as effective as open for curing cancer, but that laparoscopic colectomy conferred greater benefits to patients, including better cosmesis, fewer wound infections, less inflammatory response, decreased postoperative pain

and quicker return to normal activities.

“The only reason laparoscopic colectomy was eventually accepted was because of these trials,” said Dr. Whelan.

Current Landscape Despite compelling evidence of a benefit, many surgeons still do not offer laparoscopic colectomy to patients.

According to Drs. Whelan and Franklin, less than 30% of all colectomies are performed laparoscopically.

Over the next decade, as more surgical residents are trained in MIS techniques, laparoscopic colectomy may become more standard.

“Surgical residents are being exposed to laparoscopic colectomy, so the hope is that much of the future of resectional colorectal surgery will be minimally invasive,” Dr. Fowler said.

Still, making laparoscopic methods more widespread continues to be a challenge. Hand-assisted laparoscopic surgery (HALS), developed by Drs. Ballantyne and Leahy in 1993, represented one of the first attempts to bridge the gap between open and laparoscopic techniques. With HALS, surgeons make a slightly larger incision compared with laparoscopic surgery, but studies show that patients experience many of the same benefits (Dis Colon Rectum 2008;51:818-826).

“HALS is an enabling technology for colorectal surgery,” Ms. Cohen said.

“The procedure becomes much easier to perform when surgeons can insert their hand in the belly to feel the anatomy and tumor site, just like they do in an open case.”

Surgical robotics is another MISenabling technology. The da Vinci Robot, for instance, is designed to restore sensory perception and give surgeons more intuitive control of their instruments.

However, according to Dr. Wexner, the expense of the technology has limited its widespread use, and studies have consistently failed to show that the robot is superior to laparoscopy despite significantly more time and expense.

“I think many surgeons are struggling with these laparoscopic techniques, which is why they use tools such as HALS and robotics,” Dr. Franklin said.

“However, I don’t think these tools are the answer. Mastering difficult laparoscopic techniques is about constant exposure, hard work and revision. I continue to modify my technique even today.”

Reflecting on the past 25 years of surgery, Dr. Jacobs recalls how laparoscopy gave him a new perspective on his profession. “I never wanted to be the first at anything, but the benefits of laparoscopy became obvious when we saw how we helped patients,” he said. “It was truly exciting to be part of a change that revolutionized surgery.”

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SIMULATOR

jContinued from page 1

and Endoscopic Surgeons (SAGES) meeting.

“Our health care training, despite the simulation movement, is still by and large the old model: See one, teach one, do one, kill one. … The patients are the ones who pay the price,” said Dr. Ziv, chair of medical education, Sackler School of Medicine, Tel Aviv University.

Dr. Ziv, a pediatrician, has spent the past 20 years trying to adapt the lessons of flight simulation training to the field of medical training.

According to his bio, this idea came to him in medical school when a fellow student committed suicide hours after failing a test. The future Dr. Ziv decided then that the testing system, both to get into medical school and to become a licensed physician, was inadequate. It focused purely on a student’s cognition. The system failed to assess the human side of being a physician.

Driven by this realization, Dr. Ziv completed his MD dissertation on peer evaluation. Later, he worked with the Educational Commission for Foreign Medical Graduates on a simulation-based program that certifies foreign immigrant doctors applying to work in the United States.

In 2001, Dr. Ziv returned to Israel and founded the Israel Center for Medical Simulation (MSR), now “arguably one of the most effective and influential simulation centers in the world,” said Gerald Fried, MD, immediate past president of SAGES and chair of surgery at McGill University, in Montreal, Canada.

Housed in a virtual hospital on the massive Chaim Sheba Medical Center campus just outside Tel Aviv, MSR is home to more than 100 different kinds of simulators and employs more than 150 professional actors for its courses. The nonprofit center, which operates on a fee-for-service model, trains more than 10,000 health professionals in more than 60 courses annually.

Almost all health care practitioners in Israel have undergone some training at MSR. The student body ranges from medical school applicants to hospital CEOs. Among the trainees are pharmacists who learn communication skills that can help with angry patients and reduce errors; surgeons who rehearse complex procedures in a high-tech operating room simulator; and surgical residents who practice on virtual-reality simulators. MSR instructors watch everything through one-way mirrors and conduct extensive aviation-style debriefs. Even the country’s medical clowns refine their skills through courses at MSR. MSR trains health care workers for run-of-the-mill scenarios but also for the catastrophic “unimaginable” ones. Israel is known for its extensive mass casualty preparedness; much of that training is conducted at MSR. Notably, the training extends also to Palestinians; MSR uses simulation to provide trauma training for Palestinian physicians and paramedics through an affiliation with Physicians for Human Rights.

MSR’s simulation model can be used around the world to improve safety and medical training, Dr. Fried said. “This can reshape the way medical care is delivered around the world.”

The center is founded on the principle that simulationbased medical training and assessment can revolutionize the safety culture in medicine. For too long, medicine has accepted suboptimal levels of safety, said Dr. Ziv, deputy director of Sheba Medical Center, responsible for patient safety, risk management and medical education.

He likes to compare medicine to aviation. If the deaths attributed to medical errors are put into aviation terms,

Trainees perform a simulated case at the Israel Center for Medical Simulation. they amount to four Boeing 747 crashes daily, Dr. Ziv said, citing a recent controversial study in the Journal of Patient Safety (2013;9:122-128).

Medical errors disproportionately affect women, children and older patients, he added. “This is not something intentional, but these are groups, perhaps, that we do not communicate as effectively with.”

Simulation, which ranges from expensive high-tech simulators to low-tech role-playing with actors, provides an environment for people to learn by hands-on practice but without putting patients’ lives at risk, Dr. Ziv said.

“This is a very powerful way of teaching.”

Dr. Ziv pointed to data collected by the American nonprofit behavioral psychology center, the National Training Laboratory, which showed that learners who are taught by hands-on practice retain around 75% of information. In contrast, students remember about 5% of what they hear in lectures, 10% of what they read and 30% of what they see.

A key advantage of simulation is that it can teach skills needed in emergency situations, the medical equivalents of trying to land a plane with a fire in the cockpit, Dr. Ziv said. These are low-frequency but high-stakes scenarios.

MSR runs programs to teach trainees and practicing physicians how to respond in so-called “nightmare scenarios.” There is even a module known as the “nightmare course,” a mandatory five-day program for Israeli interns about to begin their first hospital rotations. They are challenged with a series of stressful situations such as finding themselves in an elevator alone at night with a patient who stops breathing.

“Or it could be the nightmare on the emotional front: telling a family that we have erred and we gave their father the wrong blood, that we are responsible for the loss of a loved one,” Dr. Ziv said.

“It’s through this kind of proactive learning, rather than [a] reactive one with our apprentice one, [that] we can enact nightmares.”

Dr. Ziv asserted that medical errors occur because of malfunctions built into the health care system from the

moment applicants are evaluated as candidates for medical school. At most medical schools, the application committee considers grades and extracurricular activities, but places little emphasis on personality traits.

But medical schools need to consider personality traits, Dr. Ziv said. And so, MSR, together with Israeli medical schools and Israel’s National Institute for Testing and Evaluation, developed an assessment program—known as MOR, a Hebrew acronym for “selection for medicine”—to measure candidates’ judgment and decisionmaking skills. Candidates complete a series of behavioral stations, including encounters with simulated patients and group tasks, an autobiographical questionnaire, and a judgment and decision-making questionnaire. They are evaluated on interpersonal communication skills, ability to handle stress, initiative and responsibility, and self-awareness.

This program resulted in a change of about 20% in the cohort of accepted students compared with previous admission criteria (Med Educ 2008;42:991-998). The investigators found very low correlation between the candidates’ MOR scores and cognitive scores.

“MOR conveys the importance of maintaining humanistic characteristics in the medical profession to students and faculty staff,” Dr. Ziv noted.

He would like to see similarly thorough assessments of physicians throughout their career. Physicians should be evaluated on all aspects of the care they provide, from their ability to deal with high-stress situations to their operative skill, he said.

“Surgeons can be operating with Parkinson’s and nobody can ground that surgeon. That’s true today around the world and it is not right.”

Dr. Ziv hoped that simulation-based medical education will spark a revolution in medicine.

“We will have to change course. We have some barriers but they are not as high as we think. The end of it, there’s the humility message that if we meet our errors in the simulation environment, we will be better off in the real world,” he said.

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PREOPERATIVE REGIMEN jContinued from page 4

because you can do a component separation, doesn’t mean you should [do it] right away,” said Parag Bhanot, MD, associate professor of surgery at the Georgetown University School of Medicine, in Washington, D.C. In a telephone interview, William W. Hope, MD, assistant professor of surgery, University of North Carolina-Chapel Hill, Wilmington, said surgeons are asking patents to take a bigger role in their health care “because these hernias are so difficult to treat.

“The complication rate is high. If patients are not going to take part in their health care, if they aren’t going to do something to help, then a lot of times these hernias are not fixable or not fixable in a good way. We can withhold surgery or postpone surgery,” said Dr. Hope, who was not one of the panelists at the AHS session.

Dr. Martindale said as many as 30% to 40% of patients who undergo abdominal wall reconstruction experience complications, putting these procedures in the same high-risk group as major gastrointestinal procedures like pancreatic surgery and esophageal surgery.

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woound in nfection rate than never-smokerss at 122% versus 2%. Notably, smokerss who quit four weeks before surgery red duced ttheir wound infection rate to a levvel simiilar to never-smokers (Ann Surg 20003;238:1−5). “ “Smoki king is simply non-negotiable,” said Dr. R Rosen. ““I thin nk the biggest mistake all of us maake as surgeons is thinking ‘I’m just a bettter tech hnical surgeon at every level’ but thee truth is you’re not. It’s going to catch up to you u. For me, I stack the deck in my favvor. Sm moking cessation is part of that.” see PREOPERATIVE REGIMEN page 17

‘I think the biggest mistake all of us make as surgeons is thinking “I’m just a better technical surgeon at every level” but the truth is you’re not. It’s going to catch up to you. For me, I stack the deck in my favor. Smoking cessation is part of that.”

—Michael Rosen, MD

With rates so high, surgeons need to identify areas where they can reduce complications, said Dr. Martindale.

He argued that there are numerous opportunities plenty of opportunities to reduce risk for complications in the preoperative period. “There is growing data, certainly lots of data now that we can prevent some [complications] with preoperative planning.”

The panelists at the AHS meeting said they considered smoking cessation one of the most critical steps that patients should take before undergoing hernia repair.

Multiple studies demonstrated that preoperative smoking cessation makes a difference in surgical outcomes. One of the best-known studies to look at this issue, published in 2003 in the Annals of Surgery, showed smokers have a much higher

Discover the Next Frontier for Minimally Invasive Surgery Serious complications may occur in any surgery, including da Vinci® Surgery, up to and including death. For Important Safety Information, indications for use, risks, full cautions and warnings, please also refer to http://www.davincisurgery.com/safety and http://www.intuitivesurgical.com. Spontaneous opinions expressed during live presentations by participants belong to those individuals. These opinions are not necessarily be shared by Intuitive Surgical, Inc. © 2014 Intuitive Surgical, Inc. All rights reserved.

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In the News RECTAL CANCER jContinued from page 1

president of the European Association for Endoscopic Surgery (EAES), organized an international, multidisciplinary panel at the 2014 EAES meeting in Paris to help unify and optimize the treatment of early rectal cancer.

After combing through the literature, the panel members presented the best recommendations for the perioperative care of early rectal cancer based on the existing evidence.

“This consensus congress was a very positive experience on an important topic that needs robust guidelines,” said Regina Beets-Tan, MD, PhD, professor in the Department of Radiology, Maastricht University Medical & Oncology Center, The Netherlands.

Yves Panis, MD, head of the Department of Colorectal Surgery, Beaujon Hospital, Paris, agreed, stating, “It was a strong panel of surgeons, gastroenterologists, radiologists and pathologists who worked well together to answer all questions related to the treatment of early rectal cancer and to create the consensus guidelines.”

But, Dr. Panis noted that for many statements, the level of evidence was low because few, if any, prospective randomized controlled studies exist. “Thus, a

RECOVERY

jContinued from page 1 colorectal surgeon at Yeovil District Hospital in Somerset, England. “Our ongoing research is working to uncover the key factors in perioperative care.”

Although no standard ERAS protocol yet exists in colorectal surgery, most include formal patient education, eliminating bowel preparation and allowing clear fluids up to three hours before surgery. Intraoperatively, studies show that laparoscopic surgery, goal-directed fluid management, less operative time and reduced blood loss aid patient recovery ( S 2014;18:265-272). Postoperative(JSLS ly, the use of thoracic epidural analgesia, avoidance of nasogastric tubes, and early feeding, mobilization, discontinuation of IV fluid and removal of urethral catheters are important features as well (Ann ( Surgg 2000;232:51-57).

Despite the lack of consensus, a growing body of research shows that employing ERAS principles reduces hospital length of stay and complications in colorectal surgery ((Ann Surg 2000;232:51-57; Br J Surg 2006;93:800809; Anesth Analgg 2014;118:1052-1061).

For instance, in a 2014 study comparing outcomes in a traditional care (99 patients) and ERAS group (142 patients), Julie Thacker, MD, and her colleagues at

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / AUGUST 2014

consensus was often based on literature reviews, retrospective studies and personal experience.”

When defining an optimal effective preoperative workup, Dr. Beets-Tan reported that every patient should have a physical examination, a test for carcinoembryonic antigen levels, a digital rectal examination that may include a rigid proctoscopy and a total colonoscopy (level 2, grade B, consensus 100%). Additionally, Dr. Beets-Tan found strong evidence in favor of endoscopic ultrasound for staging small rectal tumors (T1) and magnetic resonance imaging (MRI) for staging T2 or large tumors (level 2, grade B, consensus 100%).

“The imaging guidelines are strongly evidence-based for local tumor staging,” said Dr. Beets-Tan. But, she added, further work is required to detect lymph node metastases, and she is currently conducting a multicenter study in The Netherlands to validate the use of dynamic contrast-enhanced MRI. The panel then focused on delineating the best method for treating early rectal cancer. “To me, the most important elements of the guidelines are defining the limits of local incision and choosing the best technique for patients,” Dr. Panis said.

To this end, the panel said that local excision is most effective for treating T1 N0 lesions with favorable clinical and

pathologic features (level 4, grade C, consensus 100%). For lesions with less favorable clinical and pathologic features, the panel advocated neoadjuvant therapy followed by local excision to preserve the rectum (level 2b, grade B, consensus 90.9%).

When performing a local excision, Dr. Panis advised endoscopic submucosal dissection (ESD) or transanal endoscopic microsurgery (TEM) (level 4, grade C, consensus 90.9%). When comparing the efficacy of ESD and TEM, however, the evidence did not clearly favor one technique over the other: In a recent meta-analysis, experts found that TEM provided better R0 resection rates (88.5% vs. 74.6%; P<0.001) but worse recurrence rates (5.2% vs. 2.6%; P<0.001) (Surg Endoscc 2014;28:427-438).

“Choosing the best technique for the patient is a critical element of care, and we need to adapt to each patient’s individual needs to achieve this goal,” Dr. Panis said. “Ultimately, the goal is to preserve the rectum in early rectal cancer.”

For patients with T1-2 N0 rectal cancer who are considered high risk for surgery, the panel recommended using neoadjuvant chemoradiation therapy followed

by TEM (level 2b, grade B, consensus 90.9%). The panel cautioned, however, that until further evidence emerges, lowrisk patients should only undergo this

procedure within a clinical trial setting.

When determining when a more radical approach is warranted, Tonia YoungFadok, MD, FACS, FASCRS, professor of surgery and chair of the Division of Colon and Rectal Surgery, Mayo Clinic College of Medicine, Phoenix, reported the panel’s conclusion that complete resection of the rectum using total mesorectal excision, or TME, should be performed when biopsy and imaging indicate that local excision is inadequate or when local excision shows the lesion is more advanced than expected (level 2a, grade B, consensus 90.9%). Another reason to opt for a more invasive approach is patient preference.

In terms of the patients’ quality of life after surgery, the evidence strongly points to laparoscopic over open surgery in most cases, considering the advantages of shorter length of stay and postoperative complications (level 1a, grade A, consensus 100%).

Commenting on what the future holds, Dr. Panis said, “We will continue to review and revise the guidelines, but today the idea is to publish these recommendations quickly to help unite the treatment protocols for early rectal cancer worldwide.”

The full consensus guidelines will be published within the year in Surgical Endoscopy.

Duke University Medical Center, Durham, N.C., found that patients following an enhanced recovery protocol had a significantly shorter length of stay (five vs. seven days; P<0.001), fewer urinary tract infections (13% vs. 24%; P P=0.03), reductions in duration of ileus and lower readmission rates (9.8% vs. 20.2%; P=0.02).

P The Duke enhanced recovery protocol was also associated with lower medical costs, about $2,000 per patient or a 10% decrease in the costs of traditional care.

“This reduction in cost is a huge bonus for patients and the health system,” said Dr. Thacker, assistant professor in the Department of Surgery. “It could save hundreds of thousands of dollars a year and would require minimal to no extra costs for hospitals to realize.”

But, given the abundance of perioperative factors being studied and the complexity of different health systems, ERAS can be difficult to implement. In a 2012 study (Colorectal Diss 14:e727-e734), Dr. Francis and his colleagues retrospectively analyzed outcomes of 385 patients who underwent elective laparoscopic or open colorectal resection at Yeovil District Hospital between 2002 and 2009, and found that 31% of patients stayed more than one week (delayed discharge), and 41% deviated from the ERAS protocol. The authors concluded that failing to comply with ERAS one day after

‘It could save hundreds of thousands of dollars a year and would require minimal to no extra costs for hospitals to realize.’

enhanced recovery for colorectal surgery, and their payment schemes are tied to protocol compliance. “Over the last 10 yyears, we’ve seen an amazing spread of ERAS,” Dr. Francis said. “The proERA gram m n now exists in every hospital in Englan land.”

But loo ooking beyond the United Kingdom m to the rest of Europe and the United States, ERA AS is not taking hold as quickly. q “National mandates, transparent audits da and government-funded implementation efforts in the U U.K. create a very different picture than surgeon and anesthesiologist-driven work in the U.S.,” said Dr. Thacker. “Trying to change a little bit about everything included in perioperative care in the U.S. is extraordinarily challenging.”

Part of the difficulty is that each hospital in the United States has different capabilities and guidelines, which means the challenges to implementing an enhanced recovery protocol will vary by hospital, Dr. Thacker noted.

Despite these complex barriers, Dr. Thacker has started to garner support from surgical societies throughout the United States. “The more interest we get at the society and health system level, the easier it will be to improve perioperative care.”

—Julie Thacker, MD surgery was strong ngly associated with delayed ed discharge.

In a recent analysis, Dr. Francis and his colleagues tried to determine what factors cause patients to deviate from an enhanced recovery protocol. After prospectively collecting data from 178 patients who had undergone open or laparoscopic colorectal surgery between January 2006 and December 2009, the surgeons found that of the 32% of patients who deviated from the program, the most common reasons cited were failure to mobilize after surgery (80.7%), continued use of IV fluids beyond 24 hours (59.7%), failure to resume an oral diet (45.6%) and inadequate pain control (10.5%).

The adoption of ERAS across Europe and the United States has also seen varied success. In the United Kingdom, hospitals are encouraged to adopt

In the News

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PREOPERATIVE REGIMEN jContinued from page 15

At Oregon Health & Science University, Dr. Martindale requires patients to undergo a complete methicillin-resistant Staphylococcus aureuss protocol and get their body mass index (BMI) below 50 kg/m2 before surgery. He plans to lower the BMI cutoff to 45 in the near future.

“We need to have patients lose weight,” he said. “Now, some patients do and some don’t.”

In a presentation outlining the research on preoperative optimization of patients, Dr. Martindale said the only hard data demonstrating a surgical benefit from preoperative weight loss is in the bariatric surgery literature.

Countless studies show that patients with an elevated BMI face a substantially increased risk for complications after surgery compared with other patients.

This is particularly true for complex abdominal wall reconstructions. Thus, surgeons believe that patients who lose weight before these major operations have a greater likelihood of achieving a better outcome.

The cross-sectional ratio of fatto-lean body mass is also a very good predictor of surgical outcomes, specifically for pancreatic, colorectal, lymphoma and esophageal operations, said Dr. Martindale, an expert in surgical and nutritional patient care. His own unpublished research indicates the ratio of fat-to-lean body mass is predictive in abdominal wall reconstruction, as well.

He recommended screening patients with the nutritional risk score (NRS 2002), a tool popular in Europe but not in the United States. Patients who are nutritionally depleted should undergo a “nutritional tune-up” before surgery, he said. Randomized studies have shown that metabolic modulation reduces infectious and noninfectious complications, and shortens hospital length of stay. This trend is particularly pronounced in patients undergoing major open gastrointestinal surgery ((Ann Surg 2012;255:1060-1068).

Dr. Martindale suggested that patients have a target for perioperative blood glucose between 140 and 180 mcg/dL and preoperative hemoglobin

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A1c lower than 8% “or even 7.5% if you want to push it.” Elective procedures in patients with higher levels should be rescheduled for a later date when their glucose is under control, he said.

Another recommendation from the panel dealt with carbohydrate-loading. Dr. Martindale suggested giving patients an isotonic glucose solution the night before surgery and again two to three hours presurgery. When patients are kept NPO after midnight, their bodies will burn through their carbohydrate reserves, Dr. Martindale said. The stress of surgery bumps their insulin,

inhibiting lipolysis and causing the body to burn more lean body tissue to supply gluconeogenic substrate to those tissues requiring carbohydrates. Carbohydrateloading strategies have been embraced in colorectal surgery and form part of the Enhanced Recovery After Surgery protocol (World J Surgg 2013;37:259−284).

Guidelines from the European Society for Clinical Nutrition and Metabolism stipulate that carb-loading is an accepted form of metabolic preparation.

“In this country now, there are various solutions being marketed than you can purchase. I basically use a

commercially available athletic drink that has been diluted to isotonic levels,” Dr. Martindale said.

Dr. Martindale also recommended testing vitamin D levels and placing patients with levels below 30 on a vitamin D protocol. Dr. Martindale and his colleagues published a detailed review of strategies for effective preoperative nutrition optimization in 2013 and 2014. The manuscripts are available in the journal Nutrition in Clinical Practice (2014:29:10-21) and Surgical Clinics of North America 2013.

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Surgical Robotics

PARTICIPANTS

The mechanisms and three-dimensional (3D) vision of the robot allow for maneuvering in tight spaces and enhanced viewing of smaller areas compared with the laparoscopic approach, and it provides the surgeon the capability to manipulate tissue and improved performance of surgery, as well as reducing surgeon fatigue.

Additionally, robotic surgery has been proven to provide clinical patient benefits of less pain, faster recovery time (and shorter hospital length of stay and less postoperative pain medication), generally reduced blood loss and improved cosmesis.

Yuman Fong, MD, is the Murray F. Brennan Chair in Surgery at Memorial Sloan-Kettering Cancer Center, New York City.

Dr. Jones: Disagree. Despite 3D and maneuverability, there is no proven benefit for most operations.

The bigger SILS [single-incision laparoscopic surgery] port may actually cause more pain and more hernias and be more disfiguring than needle laparoscopy.

Daniel Jones, MD, MS, is chief, Minimally Invasive & Bariatric Surgery at Beth Israel Deaconess Medical Center, and professor of surgery, Harvard Medical School, Boston.

Dr. Williams: Agree. In transoral robotic surgery [TORS], radical prostatectomy and most gynecologic procedures, the robot is far superior to traditional open and laparoscopic approaches.

Omar Yusef Kudsi, MD, MBA, is assistant professor of surgery, Tufts University School of Medicine, Boston.

Marty Makary, MD, MPH, is associate professor, Surgery and Health Policy at Johns Hopkins University, and director, Minimally Invasive HPB Surgery, Johns Hopkins Hospital, Baltimore.

Frank Rosato, MD, is director of gastrointestinal surgery, Capital Health Hospital, Pennington, New Jersey.

Noel N. Williams, MD, is professor of surgery at the Perelman School of Medicine at the University of Pennsylvania, and director of the Penn Metabolic and Bariatric Surgery Program, Philadelphia.

Dr. Makary: 3D vision and added degrees of freedom may benefit patients undergoing select operations in which tight spaces cannot otherwise be reached by standard laparoscopy (e.g., posterior pharynx surgery). Future versions of the robot will expand these select indications. The benefit to a surgeon’s spine is noteworthy in some operations (e.g., prostatectomy) where bending over to perform standard laparoscopy is known to cause occupational injury. The framing of the question of whether robotic surgery is proven to yield less pain, recovery time and blood loss is precisely the problem with the robotic surgery controversy—the question of superiority lacks a comparison group (is it open or standard laparoscopic surgery?), does not specify for which operation type, and ignores the publication bias of underreporting of the rare but catastrophic complications associated with the lack of haptic feedback. Sound byte claims of robotic superiority are largely unfounded, unfairly crediting the robot with minimally invasive surgery [MIS] benefits over open surgery.

Dr. Fong: Agree. There is no doubt that the 3D vision and the articulated instruments offer technical advantages and allow more complicated operations to be performed in an MIS environment. Proving that this translates to better patient outcomes has been

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agreement on a few major aspects of robotics—most interestingly, the opinion that robotics doesn't necessarily mean more risk for inadvertent injury than with open or laparoscopic surgery. Robotics will continue to be a subject for which spirited debate and technological advancement progress in parallel.

General consensus was also reached on one more important point—the robot is not only here to stay, but will continue to advance, and surgeons would be wise to advance with it. Otherwise, as Dan Jones, MD, said, the robotic surgeon may soon be eating your lunch!

Thank you to this month’s contributors for sharing their thoughts and expertise. Please feel free to email me at colleen@cmhadvisors.com with thoughts on this month’s column, or ideas for future ones.

—Colleen Hutchinson

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In one of his blog posts, Toby Cosgrove, CEO of Cleveland Clinic Foundation, referenced two studies done at his institution comparing robotic surgery with traditional methods for mitral valve repair and prostatectomy. The first study found that technical complexity and longer surgical time were balanced by the benefits of shorter hospital stays and smaller incisions; the second study showed that robotic surgery was no better or worse than traditional surgery. If you follow my table that appears in this column regularly, you know that I’ve tested the waters to see how surgeons feel about this new surgical approach. The time has come to hear from surgeons beyond sound bytes and to tackle the issues in a dedicated column. While both sides are effectively represented here, and with more objectivity and balance in each individual perspective than one might expect, I was surprised to see

more difficult because of a lack of studies and poor outcome parameters.

Dr. Rosato: Disagree. Today’s laparoscopic articulating instruments and scopes provide the ability to navigate in tight spaces with enhanced visualization similar to the robot. Furthermore, the robot’s lack of tactile feedback is a major concern. The initial studies quantifying the benefits of robotic surgery were based on claims made in comparison with open approaches. More recent studies comparing the robot with laparoscopic surgery show no difference related to pain, recovery time, blood loss or cosmesis. Patients need to understand that it is who does your surgery, and not how they do it that is important.

Dr. Kudsi: Agree. I believe that the surgeon’s skill, training and incremental learning are determining factors to successful outcomes in the field of surgery and in particular robotic surgery. In regard to robotics, we, as surgeons, have the chance to shape the future, craft it and define it using our values as our moral compass. And, most importantly, when comparing robotics outcomes, experience is the No. 1 criterion a surgeon should consider prior to judging the results (3D vision, suturing, stability and control). There isn’t a single surgical tool that wasn’t dependent on practice and on a skilled surgeon to achieve the very best results. In the words of Dr. [Francis] Sutter, a robotic cardiac surgeon, “Surgical excellence revolves around one basic principle—improving upon the existing procedure, making surgery safer and easier for the patient and surgeon.” Robotic surgery versus laparoscopic surgery is an ongoing comparison, but those judging are missing the point that robotics is another tool that, in the right hands of dedicated surgeons and programs, could deliver phenomenal outcomes. Robotics is an instrument to achieve excellence.

On the Spot

Dr. Fong: Disagree. The way to make this technology available to all is not to just pass it off into the “third-party payor pool.” To make it available to all, we need to optimize robot use by using standard laparoscopy for those MIS procedures where robotics adds no advantage but does add cost. Because surgical robotic products are currently a monopoly, we should consider having it regulated as such. All essential services that are monopolies are usually regulated by the government for charges.

Dr. Williams: On the fence. Clearly there are operations where the robot is far superior to standard laparoscopic approaches. In these instances, they should be reimbursed by the third-party payors.

Dr. Jones: Disagree. No reason to jack up health care costs and insurance premiums. Technology must prove to be cost-effective.

’As a society, how do we justify doing robotic cholecystectomy when there is an established, safe laparoscopic approach that costs thousands less per operation?’

—Martin Makary, MD Dr. Makary: Any medical intervention that benefits our patients should be paid for, but is it really better for gallbladder surgery? As a society, how do we justify doing robotic cholecystectomy when there is an established, safe laparoscopic approach that costs thousands less per operation? We should remember that we currently have rationing of health care in America.

Arizona has let, and continues to let, patients die on transplant waitlists simply because the state insurance program cannot afford the expensive procedure.

We should consider our larger mission to the public.

Dr. Rosato: Disagree. Although the effectiveness of the robot has been shown in a myriad of surgical procedures, its superiority over more traditional and less costly approaches has never been proven. The goal of every physician should be to deliver effective and efficient health care. The robot adds expense to every case performed.

Using it for surgeries in which there is

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The effectiveness of the robot is proven in many operations, but it is clearly more expensive. As we are a society with ample resources, the extra cost of this technology should be paid by third-party payors so that it is available to all.

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no proven superiority is not cost-effective. We are not a society of unlimited resources, and although third-party payors are covering the added expense of robotic cases currently, it will be only a matter of time before that extra cost will be passed along to patients.

Dr. Kudsi: Agree. Most famous

institutions and schools in the United States have a fair amount of their resources paid by third parties (donations), and many surgical centers in Europe, Middle East and Asia were donated. I do believe that [robotics] shouldn’t be considered as the only approach, but the percentage for the next decade will definitely grow.

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On the Spot

Dr. Fong: Agree. This is where a society such as SAGES [Society of American Gastrointestinal and Endoscopic Surgeons] could be quite helpful, providing guidelines similar to those drafted for laparoscopy. We need sensible guidelines that provide for patient safety while allowing room for innovation. Having experts in the field preemptively define these will prevent onerous guidelines that may result from a reaction to an untoward event.

it will continue to accelerate in the near future. We as surgeons and surgical trainees are faced with the dilemma of whether to adopt robotics. We should consider four basic questions: What is the learning curve in robotics? How much commitment is needed to achieve excellent results? Does robotics add value to the existing options? Is it financially viable?

From the point of view of a robotic

Dr. Jones: Agree. Next-generation robots are the future. We will realize technological breakthroughs sooner if we get the robots into the hands of trainees and multiple vendors.

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Institutions and surgical societies need to establish a standard resident and attending curriculum for learning robotic skills to proficiency— and to not do so is to allow for a continuation of the current environment of the self-made robot expert. Residents and fellows should be trained in the technology so that they can apply it rationally and help develop the next generation of robotic interfaces.

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surgeon, and someone who has done hundreds of robotics in the field of general surgery, I could simply say that it is a phenomenal tool that permits the surgeon to deliver state-of-the-art results to his or her patients. The potential of robotics is yet to be discovered, especially with the new generation of motivated surgeons in the field of robotic surgery.

In regard to teaching facilities, robotics

‘From the point of view of a robotic surgeon, and someone who has done hundreds of robotics in the field of general surgery, I could simply say that it is a phenomenal tool that permits the surgeon to deliver state-of-the-art results to his or her patients.‘

Dr. Kudsi: Agree. The pace of innovation in surgery change has increased substantially over the past decade, and

—Omar Yusef Kudsi, MD, MBA

might provide a more controlled environment with the teaching console in comparison with laparoscopic surgery.

Dr. Williams: Agree. In our institution, all the residents are required to do a standard simulation curriculum before sitting at the console. We also have a simulation lab with Box Trainers stomach models to do full simulated operations before patient exposure at the console.

Dr. Makary: I agree, for everything we do in surgery.

Dr. Rosato: Agree. If we continue to allow industry to define training criteria and determine proficiency standards, the true indications for robotic use and the maximum benefit of this technology will never be realized.

Gut Reaction: Robots and More IBM’s Watson Worst abuse of the robot right now

American College of Surgeons (ACS)

Society of American Gastrointestinal and Endoscopic Surgeons (SAGES)

Best advice to the community surgeon on robot adoption

FDA’s approval process for medical devices

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The one thing I forget most is …

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Consider it on a case-bycase basis.

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On the Spot

Dr. Williams: Agree. If a hospital has a major robotic program, there should be a dedicated OR [operating room] staff that knows how to handle emergencies in an expeditious manner to allow for rapid conversion to an open procedure. This scenario should be practiced in a simulation setting on a regular basis or when new staff members join the team. Teamwork is very important between OR staff and the surgeons.

cases. Ultimately, it is the responsibility of the surgeon to assure that the team is prepared for any type of robotic emergency.

Dr. Fong: Agree. The essentials for a rapid and potentially lifesaving emergency conversion to an open operation are 1) immediate availability of open instruments and self-retaining open retractors; 2) rehearsal of emergency conversion and emergency time-out at beginning of case to define; and 3) document each participant’s role.

Dr. Jones: Agree. We recently had a robot stuck over a patient when a medical student tripped over the electrical plug. We have simulation labs to practice

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scenarios as teams. We should mandate that all teams must practice crisis response.

Dr. Kudsi: Agree. Despite the fact that many hospitals have formed robotic committees with rigid restrictions, some of these features are very useful. As surgeons, we should be the most experienced in the room with regard to the machine and troubleshooting. Commitment to understand and go beyond just technical skills will demonstrate leadership skills. Understanding how to dock, drive and position trocars is as important as performing the surgery to prevent instrument and arm collisions. That’s why troubleshooting and emergency conversion should be part of the team training.

Dr. Jones: On the fence. Although the surgeon may be able to see better, one gives up haptic feedback.

Dr. Kudsi: Disagree. Robotics might provide a more controlled environment with the teaching console in comparison with laparoscopic surgery, almost similar to open surgery. Injury to a major structure could happen in anyy approach; it’s related to technical and judgment skills. You can’t blame the slave robot.

Dr. Makary: Agree, but the added risk is minimal, even negligible in the hands of a good robotic surgeon.

Robotic surgery can be safe when the surgeon is experienced and is

Dr. Fong: Disagree. Inadvertent enterotomies occur in open, laparoscopic and robotic surgery. It will be important to document those injuries that would not have occurred with open surgery (e.g., trocar, vascular and traction injuries because of excessive robotic force). These should be graded according to 1) no immediate or long-term adverse outcome, 2) immediate adverse outcome but no longterm disability and 3) both immediate and long-term adverse outcome.

Dr. Williams: Disagree. There is a risk for inadvertent injury during all forms of surgery, and no more so in robotic surgery if an appropriate training model proctoring has taken place.

Dr. Fong: Agree. These should be tracked for all forms of surgery: open, laparoscopic and robotic. The lateral spread of heat for each energy instrument in open, CO2 [carbon dioxide] environment and air insufflation environment at common settings should be part of the package insert for each instrument. Education curriculum should teach use of each of these instruments in open, laparoscopic and robotic deployment.

Dr. Kudsi: On the fence. This is the greatest point of all. As a FUSE member and a robotic surgeon, I emphasized this point from day 1 in practice. In robotic surgery you are zoomed in more in comparison with laparoscopic surgery, where you usually have a larger surgical view. In being zoomed in and having long instruments, often you don’t get to see the whole instrument and adjacent structures.

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the right surgeon for that operation.

Patients should choose a good surgeon first and the approach second.

As we continue to learn more regarding safety from SAGES’ Fundamental Use of Surgical Energy (FUSE) program, we need to appreciate the potential hazard from stray currents and iatrogenic burns with use of the robot and instruments in parallel.

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Dr. Rosato: Disagree. Inadvertent injury to a major structure is an inherent risk for alll surgical approaches.

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Inadvertent injury to a major structure is a risk inherent in robotics compared with both laparoscopic and open approaches.

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Dr. Makary: Agree, and it’s for this reason—the need for quick conversion— that I have a preference to not use the robot for laparoscopic Whipples, where major portal vein bleeding can require rapid conversion.

Dr. Rosato: Disagree. At the institutions where I have worked, there has always been a dedicated operating room team for robotics. Each member, from anesthesia through circulating nurse, is well aware of the unique safety concerns presented while performing robotic procedures. Furthermore, for high-risk procedures with the potential for massive hemorrhage, I meet with our robotic team 24 hours before [the procedure] to review the case and expectations of all members should an emergency arise. As the applications of the robot are being applied to more complex and high-risk procedures, the importance of the rapid response will only increase. I am sure that I am not unique in my approach to these

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Regarding safety, in the event of an acute life-threatening iatrogenic bleed, the entire surgical team needs to respond quickly to remove the robot.

Several case reports in the literature detailing the patient being stuck under the robot call for quick team response to be regularly practiced, yet this practice need is not being met currently within institutions or within the larger scope of surgical education.

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / AUGUST 2014

We have to be aware and educated about SAGES [FUSE], and I invite all surgeons to take the course and the actual test.

Dr. Rosato: Agree. This applies to all minimally invasive approaches used for treating surgical problems. Limiting the use of monopolar energy in favor of bipolar or alternative energy devices is paramount for patient safety.

Dr. Jones: Agree. Especially when doing SILS, where instruments are closer together, there is a potential danger. Take FUSE and you will change the way you do SILS forever, if ever again.

Dr. Williams: Agree. The understanding of energy sources is mandatory for all surgeons performing robotic and laparoscopic surgery.

Dr. Makary: I agree; this is true for all minimally invasive surgery.

On the Spot

Dr. Fong: Agree and disagree. Although it is true that some medical centers will form robotic surgery programs to be “competitive,” the truly innovative centers that have invested in large academic programs in robotic surgery have included technical development, outcomes research and education as part of the program. Developing new tools, defining the advantage and disseminating the knowledge are key to truly innovative programs.

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Dr. Williams: On the fence. This statement applies to lap cholecystectomy. But for example, for cases of patients undergoing laparoscopic sleeve gastrectomy who have a very high BMI [body mass index], I feel it

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‘I usually can do two laparoscopic cholecystectomies and have a cup of coffee in the doctors’ lounge in the time my colleague does one robotic cholecystectomy. But he may soon be eating my lunch.‘ —Daniel Jones, MD is safer and more precise to use the robot. In our institution, robot setup time does not add any time to the overall procedure.

Dr. Jones: Agree. I usually can do two laparoscopic cholecystectomies and have a cup of coffee in the doctors’ lounge in the time my colleague does one robotic cholecystectomy. But he may soon be eating my lunch since the photo opportunity is with the million-dollar robot and not the laparoscope these days.

Dr. Makary: On the fence. Some surgeons and hospitals may use the robot for marketing, evidenced by robot debuts at community half-time events and shopping malls. And although some even mislead the public with unethical marketing to patients who are in a vulnerable state and shopping for quality surgery, I believe many surgeons are simply trying to be proficient with a futuristic technology. As new robot versions come out

There is catch-up work to be done: Generally speaking, at centers where the robot is currently used, protocols that both ensure proper patient selection and fully inform patients of risks and benefits of all surgical options are lacking.

Dr. Fong: Disagree. At most academic medical centers, robotic surgical time is a valuable commodity. It is usually assigned to the procedures and programs of greatest promise. Credentialing processes are rigorous and include auditing of outcomes.

Patients certainly must give informed consent before undergoing such an operation.

Dr. Jones: The robot is marketed as “cool” and “cutting-edge.” The surgeons who use it say it makes their operations easier and possibly better; so, no surprise, the patient signs. If the patient, rather than the insurance company were paying part of the added costs, the patient might have more questions or find a surgeon who does as well without the need for costly robotic assistance.

Dr. Kudsi: I agree, despite the fact that many hospitals have formed robotic committees with rigid restrictions and details beyond practicality at some hospitals and others driven by media and fear of lawsuits. Developing high-performance robotic surgery teams requires leadership—not the authoritarian leadership of the past, but the kind of leadership that fosters exceptional communication, mutual respect and support, and the development of the best and most straightforward to achieve the goals of our surgical society. Recently, SAGES created Minimally Invasive Robotic Association guidelines, and it will continue to evolve.

Dr. Makary: The key is for patients to be fully informed of all their options.

Stakeholders should have created a robust,

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Dr. Rosato: Agree. A 2011 study published in the Journal for Healthcare Qualityy [33:48-52] and conducted by Johns Hopkins School of Medicine [Baltimore] researchers found 41% of hospital websites described robotic surgery. Among these, 37% presented robotic surgery on their home page; 73% used manufacturer-provided stock images or text; and 33% linked to a manufacturer website. Statements of clinical superiority were made on 86% of websites, with 32% describing improved cancer control, and 2% described a reference group. None of the hospital websites mentioned risks.

These investigators concluded that materials provided by hospitals regarding the surgical robot overestimate benefits and largely ignore risks, and are strongly influenced by the manufacturer. [Editor’s note: Dr. Makary was an author on this paper].

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Although robots will one day replace many precision human tasks in the OR, currently very few operations are really done better with a robot when performed by a skilled surgeon. Therefore, currently many surgeons and medical centers are really using the robot to gain a marketing edge against competition and to attract new patients, rather than to provide for safer, improved operations and clinical outcomes for their patients.

and new companies introduce next-generation robots, surgeons are smart to keep an open mind and evaluate the application for their practice mix.

Dr. Kudsi: Disagree. I can say in all confidence that it would take me less time to perform robot-assisted laparoscopic cholecystectomy than laparoscopic cholecystectomy on a personal level—skin to skin in less than 30 minutes with room turnover time less than 15 minutes from a team perspective. It was recently published in HBR [Harvard Business Review] that once you have a dedicated surgical team, the whole day becomes efficient, your outcomes are excellent and it is more fun!

It is similar to many surgeons in their surgical centers. Robotic surgery will not cause less pain and lead to faster recovery, but it will provide control over the operation where you are doing 100% of the cases, whereas in other cases you are dependent on the assistant performance and skill level. How many of us will change his or her face when a lesser-skilled assistant shows up for a morbidly obese male patient who has an acute gallbladder?

Although many centers are marketing themselves to gain a marketing edge, it’s a false hope because this road will lead nowhere.

As I previously stated, robotic versus laparoscopic surgery is an ongoing point of comparison, but misses the point that robotics is a tool that in the hands of dedicated surgeons and programs can deliver remarkable outcomes—an instrument to achieve excellence.

Hundreds of robots have been sold worldwide and the approach is being adopted across the universe. Focus should be on excellence—you better choose one surgeon and make him the robotic expert. At the end of the day, it will be a more expensive option; thus, we should find a dedicated surgeon who would ensure superb results.

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“capture-all” registry for all robotic surgery patient outcomes 12 years ago when the robot was FDA-approved. This endeavor would have allowed researchers to evaluate the benefit or harm to patients in real time. National registries in health care require a broad investment, but are badly needed.

Dr. Rosato: Agree. It is time for a national database for robotic procedures.

This will allow for the evaluation of proper indications, as well as short- and longterm outcomes.

—Colleen Hutchinson is a communications consultant who specializes in the areas of general surgery and bariatrics. She can be reached at colleen@cmhadvisors.com.

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / AUGUST 2014

STITCH

jContinued from page 1 among surgeons for the â&#x20AC;&#x153;small bitesâ&#x20AC;? concept, particularly in Europe. Still, this approach is not commonly used.

Long-time proponent Leif Israelsson, MD, a Swedish surgeon, led the most significant trial of the smallbites technique and published the results in 2009 in Archives of Surgery (144:1056-1059). In this single-center RCT, incisional hernia rates decreased by 70%â&#x20AC;&#x201D;from 18% to 5.6%â&#x20AC;&#x201D;when shorter stitch lengths were used (P<0.001). Short stitches also were associated with a 50% reduction in wound infections.

In interpreting these outcomes, it should be noted that the study was conducted at a single center where surgeons had long advocated this approach. Dr. Deerenberg and her colleagues set out to confirm the results, using a larger and more rigorous study design.

Between 2009 and 2012, the researchers randomized 560 patients from nine hospitals to the smallbites technique or the conventional mass closure suture technique. All surgeons and residents involved in the study were trained in standardized techniques.

In the small-bites arm, surgeons applied sutures at 0.5-cm intervals with bite widths of 0.5 cm, with a 2-0 PDS plus II suture using a 31-mm needle. In the control arm, sutures were applied every 1 cm with bite widths of 1 cm, with the use of a looped 0-0 PDS plus II suture using a 48-mm needle.

In both arms, surgeons used a suture length to wound length ratio of at least 4:1. Suturing was

initiated at the ends of the incision and moved to the the small-bites approach for both obese and normalmiddle where an overlap of at least 2 cm was created. weight patients, and said itâ&#x20AC;&#x2122;s supported by high-qualiOne year after surgery, 23% of patients in the con- ty data. â&#x20AC;&#x153;Itâ&#x20AC;&#x2122;s good science. Itâ&#x20AC;&#x2122;s legitimate, and it works. ventional closure group had an incisional hernia. In Now, itâ&#x20AC;&#x2122;s been shown in a multicenter trial.â&#x20AC;? contrast, 14% of patients in the small-bites group were Small sutures reduce tension on the suture line, found to have an incisional hernia. which is particularly valuable in obese patients whose In the small-bites group, the fascia was sutured with increased abdominal pressure adds to the risk for more stitches (45 vs. 25); there was wound complications and hernia â&#x20AC;&#x2122;Itâ&#x20AC;&#x2122;s good science. a greater ratio of suture length to development, he said. wound length (5.03 vs. 4.37); and He equated the difference in techItâ&#x20AC;&#x2122;s legitimate, and it closing required more time (14 vs. niques to the differences between works. Now, itâ&#x20AC;&#x2122;s been a zipper and buttons on a piece of 10 minutes). Short-term postoperative complications, such as surclothing. â&#x20AC;&#x153;Itâ&#x20AC;&#x2122;s the same thing with shown in a gical site infection, burst abdomen an abdominal wall closure: Multiple multicenter trial.â&#x20AC;&#x2122; and hospital length of stay, did not small bites, like multiple small teeth differ by surgical technique. on a zipper, will provide much stronâ&#x20AC;&#x201D;Alfredo Carbonell, DO Surgeons who heard the study at ger closure than a few large buttons.â&#x20AC;? the meeting said they were unsure In the STITCH trial, patients were if the small-bites technique would be as successful followed for at least one year after surgery and underin the United States as in Europe, due to the higher went radiological and clinical evaluation for incisional prevalence of obesity in this country. The average body hernias. Radiological exams were far more sensitive in mass index of patients in both arms of the study was diagnosing incisional hernia, identifying 40% of her24 kg/m2, significantly lower than the American pop- nias missed by clinical exam. ulation average of 28.8 kg/m2. â&#x20AC;&#x153;Radiological examination is essential in diagnosing Dr. Deerenberg said they operated on obese patients incisional hernia; otherwise, underestimation of the using the new technique, but not on those who would incidence will occur,â&#x20AC;? Dr. Deerenberg said. be classified as super-obese. â&#x20AC;&#x153;I think the small-bites She and her colleagues previously published a report technique is better in obese patients, but we cannot say describing the study design (BMC Surgg 2011;11:2). In for super-obese,â&#x20AC;? Dr. Deerenberg said. the paper, they said incisional hernia remains the most Alfredo Carbonell, DO, associate professor of sur- common complication after median laparotomy, with gery and co-director of the Hernia Center at the an incidence as high as 30% to 35% among obese and Greenville Health System, Greenville, S.C., advocates aortic aneurysm patients.

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