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Training for laparoendoscopic single-site surgery (LESS)

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a b s t r a c t

Article history: Received 13 October 2009 Received in revised form 1 November 2009 Accepted 6 November 2009 Available online xxx

Background: Laparoendoscopic single-site surgery (LESS) is a laparoscopic surgery in which a single small incision is made, associated with the use of a special device (single-port), or several small incisions grouped in one location (single-incision) are made, through which the laparoscopic trocars are inserted. The incision is made in the abdomen, preferably in the umbilicus. Certain peculiarities are noted in this approach, such as the difficulty, and sometimes the impossibility, of centering the image, the need to move both the camera and instruments together, requiring even more delicate and precise movements than in laparoscopy. Since information on training for LESS is scarce in the current literature, the authors report their experience with five different cases of this nature, performed in two porcine models, and then discuss a training plan for LESS. Methods: Five LESS procedures were performed in two pigs using different training techniques: two (one single-port and one single-incision) transumbilical laparoscopic cholecystectomies; one right-sided single-incision laparoscopic radical nephrectomy; one single-incision transumbilical laparoscopic radical nephrectomy; and one single-port transumbilical laparoscopic nephrectomy. Discussion: Different from what was observed in the transition from open surgery to laparoscopy, the Halstedian model should not be used in the teaching of LESS since this procedure requires that professionals partner together, thus requiring not only the training of surgeons, but of the whole team. Conclusion: LESS procedures are feasible and considered as further refinements in laparoscopic techniques. However, the peculiarities and difficulties inherent in these procedures require a specific training program combining theory and practice. The authors believe that this training is essential to achieve proficiency levels before the technique can be tried on human subjects. Ó 2009 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.

Keywords: Training Teaching Video-surgery Endosurgery Laparoendoscopic single-site surgery (LESS) Single Port Access (SPA) Minimally invasive surgery Single incision

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1. Introduction

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There is no doubt that, since the late nineteenth century, surgery has been reinvented. The development of anesthetic, aseptic and even new surgical techniques has led surgeons to emerge as specialists in medicine. For several years, surgical procedures have helped establish diagnosis and treatment for diseases affecting organs in the abdominal cavity. Abdominal wall incisions, commonly referred as laparotomy or open abdominal surgery, have been traditionally used to access the abdominal cavity, and this technique remains widely used as the basis of most surgical procedures.1 Nevertheless, the art of surgery is constantly improving. The continued search for better results, inherent in healthcare

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CO RR

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Department of Surgery, Universidade Luterana do Brazil, Canoas, RS, Brazil Universidade de Passo Fundo, Passo Fundo, RS, Brazil

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Enrico Mattana Mu¨ller , Leandro Totti Cavazzola , Joaõ Vicente Machado Grossi , Mirandolino Batista Mariano b, Claúdio Morales b, Maurıćio Brun b

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* Corresponding author at: Av Montenegro 163 apt 802, Bairro Petro´polis, Porto Alegre – RS, CEP 90460 160, Brazil. Tel.: þ55 51 99625522; fax: þ55 51 21018030. E-mail address: cavazzola@gmail.com (L.T. Cavazzola).

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professionals, has led to the pursuit of approaches less invasive than conventional laparotomy, resulting, in the early twentieth century, in the performance of the first laparoscopic surgery, when surgeons adapted cystoscopes for examination of the abdominal cavity. However, until the mid-1980s, laparoscopy had significant limitations concerning abdominal approach. The laparoscope was then connected to a video camera, which significantly enhanced the potential of laparoscopy since the surgeon was left with both hands free to manipulate instruments.2 The introduction of laparoscopy was considered a revolution in surgical treatment, and, over the past three decades, this technique has offered undoubtable benefits, becoming widely used in most procedures currently available for abdominal surgery.3 Procedures that were once considered impossible to be achieved by this route are now carried out with no need of large incisions. This fast-paced evolution in surgical techniques, instrumentation and training of surgeons has not only improved laparoscopy, but also changed the way diseases located in different parts of the body are surgically treated.4

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Training for LESS technique was based on five different surgical procedures performed in two female pigs, each weighing approximately 30 kg: one single-port and one single-incision transumbilical laparoscopic cholecystectomy, one right-sided singleincision laparoscopic radical nephrectomy, one single-incision transumbilical laparoscopic radical nephrectomy, and one singleport transumbilical laparoscopic nephrectomy (Table 1). Surgical techniques were similar to those employed in the conventional laparoscopic approach, using usual laparoscopic equipment and flexible instrumentation. All procedures were performed at Universidade de Passo Fundo, southern Brazil, by a team of experienced laparoscopic surgeons, with advanced training on laparoscopy, in order to assess procedure complexity and the possibility of performing the technique in human subjects. The study was conducted in accordance with the procedures and regulating rules of research involving living animals outlined in the Brazilian Guidelines for Animal Experimentation (Cole´gio õ Animal, COBEA). Brasileiro de Experimentaça

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2. Materials and methods

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Therefore, the objective of this study is to report ﬁve LESS procedures performed in porcine models as part of a training program for LESS and then discuss a training plan for LESS.

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3. Surgical approach

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3.1. Anesthetic induction

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In all cases the pigs received general anesthesia with isoﬂurane in 100% O2 after pretreatment with morphine sulfate (15 mg) and acepromazine (3 mg), coadministered intramuscularly, and induction with propofol (120 mg, IV). Whenever necessary, the animals received rescue analgesia with fentanyl citrate (0.75 mg, IV). Vascular access was made available throughout the procedure for the administration of lactated Ringer’s solution.

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3.2. Abdominal approach

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The pigs were initially secured in supine position and submitted to one of the following three approaches: one pig underwent cholecystectomy and nephrectomy using the umbilical route through a single cutaneous incision (single-incision) and the other animal underwent cholecystectomy and nephrectomy using the umbilical route through a single point of entry (single-port). The experiment was complemented with the use of a single-port access in the animal’s right side, parallel to the pig mammary line (similar to access sites in the anterior axillary line in humans). Based on these different approaches, the authors could include ﬁve different procedures in the training method.

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3.2.1. Single-port transumbilical laparoscopic cholecystectomy The single-port device (TriportÔ – Advanced Surgical Concepts, Ireland) was inserted through a 3-cm umbilical incision (Fig. 1), as

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Table 1 Procedures used in the training for LESS.

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Benefits secondary to this new approach, such as pain reduction in postoperative inflammatory response, quicker return to normal daily activities, decreased wound complications (infections and incisional hernias), among others, have been extensively demonstrated in numerous studies worldwide.1,4–7 Surgical techniques to access the abdominal cavity have developed greatly since the introduction of laparoscopy. Thus, the advances in minimally invasive surgery have provided further improvement in endoscopic therapy.8 The first experimental natural orifice translumenal endoscopic surgery (NOTES) was reported in 2002, when Gettman et al. performed the first transvaginal laparoscopic nephrectomy.9 Two years later, Kallo et al. reported their experience with transgastric exploration of the peritoneum in a porcine model.10 Since then, this new technique of endoscopic transluminal approach for intraperitoneal intervention has been widely used.11 The potential benefits of NOTES include absence of abdominal scars, reduced postoperative pain, surgical procedures under a conscious sedation protocol, and shorter recovery time.12 Although NOTES has attracted much attention due to these potential benefits, there are few studies on the subject, and further investigation is warranted to clarify its efficacy and safety.1,13 NOTES enables abdominal access via natural orifices, such as the mouth, vagina, urethra, and anus.1 However, NOTES still has some limitations, such as access site, method of visceral closure, risk of infection, suture technology, and guidance.8 Considering the purpose of NOTES, this begs the question of whether the umbilicus is also a natural orifice.14,15 Although the answers to this question are conflicting, some reports presented new data on techniques for abdominal access performed only through the umbilicus. This technique was named Single Port Access (SPA) surgery,16 being also known as E-NOTES (Embryonic Natural Orifice Transumbilical Endoscopic Surgery), NOTUS (Natural Orifice Transumbilical Surgery), OPUS (One Port Umbilical Surgery), among others.12 In a meeting held in July 2008, the Single Port Consensus reviewed all the terminology for laparoscopic or endoscopic procedures performed through a single incision in the abdomen and proposed that laparoendoscopic single-site surgery (LESS) be used as the common term to define this procedure.17 This technique consists of a laparoscopic surgery in which a single small incision is made, with the use of a device designed to contain all instruments (single-port), or several small incisions grouped in one location (single-incision) are made to place the trocars. The incision is made in the abdomen, preferably in the umbilicus. However, the LESS Consensus also proposed that, when the incision site is the umbilicus, the procedure be called U-LESS (umbilical-LESS), highlighting that a single umbilical incision produces the best aesthetic result.18 Thus, LESS surgery has been driven by consumer demand and fueled by technological advances, becoming a step toward incisionless procedures.19 Nguyen et al. points out that the main advantage of U-LESS is aesthetic improvement, without visible abdominal scars. Disadvantages include lack of appropriate instrumentation to triangulation when compared to conventional laparoscopy.12 Similar to most laparoscopic surgeons, who needed to practice the technique in porcine models and participate in short training programs before their first surgery in human patients,20 training for LESS is crucial for surgeons wishing to acquire the skills needed to become a LESS proceduralist, although this technique has been considered less difficult to perform than NOTES. LESS is actually easier than NOTES due to its close similarity to conventional laparoscopy. However, certain peculiarities are noted in this approach, such as the difficulty, and sometimes the impossibility, of displaying surgical instruments in the center of the screen, the need to move both the camera and instruments together, which requires more delicate and precise movements than in laparoscopy.

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Single-Incision Procedures

Single-Port Procedures

Transumbilical laparoscopic cholecystectomy Transumbilical laparoscopic nephrectomy Right-sided laparoscopic radical nephrectomy

Transumbilical laparoscopic cholecystectomy Transumbilical laparoscopic nephrectomy

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Fig. 1. Special device (single-port, TriportÔ) used in two surgical procedures.

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3.2.2. Single-incision transumbilical laparoscopic cholecystectomy A 10-mm trocar was inserted through a 3-cm cross incision in the umbilicus, using the open technique, to introduce a 0-degree rigid endoscope, two other trocars being introduced craniolaterally to this one (Fig. 2). The abdominal cavity was insufﬂated to 12 mmHg and grasping clamps were introduced caudally to the camera for traction on the gallbladder infundibulum, directly through the muscle wall without using the port. The gallbladder pedicle was then dissected, and the cystic duct and artery were ligated individually with 2–-0 silk suture using intracorporeal knot tying, applied with a needle holder having a counter bore. This situation also required the occasional use of the 5-mm camera. After detaching the gallbladder from the hepatic bed, it was

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3.2.3. Right-sided single-incision laparoscopic radical nephrectomy With the pig in the left lateral position, a 2.5-cm cross incision was made, parallel to the midline and lateral to the mammary chain. Using the open technique, a 10-mm port was placed in the midpoint of the incision, and the abdominal cavity was insufflated to 12 mmHg with CO2. After extensive dissection of the subcutaneous tissue, two other ports (5- and 10-mm) were placed laterally to the first one and maintained in the same axis, one at each end of the incision (Fig. 3). Under direct visualization with a 10-mm 0-degree endoscope, the renal hilum was dissected using Maryland forceps, Metzenbaum scissors and LigaSureÔ. Three ligations with 2–0 silk suture using intracorporeal knot tying were applied, covering both the renal artery and vein. After dissection of the ureter, renal fascia and peritoneum, the kidney was excised. The procedure was performed without intraoperative complications or measurable bleeding. 3.2.4. Single-incision transumbilical laparoscopic radical nephrectomy The three-port access from a single incision was the same used in the first animal, which had undergone a single-incision transumbilical laparoscopic cholecystectomy (item 3.2.2) (Fig. 4). With the animal in the right lateral position and under direct visualization with a 10-mm 0-degree endoscope – introduced through the 10-mm port – the left renal hilum was dissected with

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removed through the wound in which the 10-mm port was placed, with no need of an extraction bag. There were no surgical complications.

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recommended by the manufacturer. This equipment consists of two 5-mm ports and one 10-mm port to insert the camera and clamps. The gallbladder was dissected following the usual procedure, occasionally using ﬂexible traction grips (5-mm Auto SutureÔ, USSC Roticulator, and Endo GraspÔ, Covidien). The cystic duct and artery were ligated with titanium clips using a 10-mm stapler, requiring the use of the 5-mm camera for the procedure, which highlights the need for rigid endoscopes of different dimensions, in addition to a team previously trained to operate them. The procedure was performed without major complications.

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Fig. 3. Umbilical incision for single-incision LESS.

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Fig. 2. Umbilical incision to perform single-incision LESS in a porcine model. In this case, three permanent trocars were used (two 5-mm and one 10-mm).

Fig. 4. Incision in the abdominal right side for single-incision LESS.

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3.2.5. Single-port transumbilical laparoscopic nephrectomy We used the same animal from the single-incision laparoscopic nephrectomy, with the use of a TriportÔ in the contralateral kidney (Fig. 5), which was introduced through a single umbilical incision of approximately 3 cm. After the abdominal cavity was insufﬂated to 12 mmHg with CO2, a 10-mm 0-degree camera was introduced through the 10-mm access route, whereas Maryland forceps and Metzenbaum scissors were introduced through the two 5-mm access routes. The renal hilum was dissected and the renal artery and vein were separated. The renal vessels were clipped proximally with Hem-o-LockÔ polymer clips and distally with titanium clips, and, for that purpose, we placed the 5-mm endoscope in the access route previously used for the scissors; thus, the staplers could be introduced through the 10-mm access route. Prior to resection, the ureter was obliterated by a titanium clip. The kidney was then dissected and placed in an extraction bag, in association with manual maceration of the organ. The TriportÔ and, subsequently, the kidney were removed through the single umbilical incision. The incision was occluded on its anatomical planes. There were no surgical complications.

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3.3. Procedure outcomes

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The mean procedure length was 45 min (30–60 min), with no measurable bleeding or other complications. The animal which underwent laparoscopic cholecystectomy followed by single-incision nephrectomy was followed up for 14 days and did not show any postoperative complications. The other animal, after cholecystectomy, underwent bilateral LESS nephrectomy and, for that reason, was euthanized after surgery with an overdose of sodium thiopental administered intravenously.

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1. Theoretical aspects: a. Difference between single-incision and single-port procedures; b. Equipment and surgical instrumentation needed for LESS; c. Deﬁnition of the target organ and incision site; d. Differences between the technique employed in the main surgeries using LESS and that employed in conventional laparoscopy; e. Need for appropriate transoperative planning;

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Maryland forceps and Metzenbaum scissors. After isolating the renal artery and vein, we switched to a 5-mm 0-degree endoscope. Two Hem-o-LockÔ clips were applied to the artery and vein, respectively, proximal to the large vessels (aorta and vena cava). Titanium clips (one in each vessel) were used to control bleeding, and the ureter was obliterated by a single titanium clip. The kidney was dissected and placed in a bag for tissue extraction. The larger incision was increased in about 1 cm so that the kidney could be removed from the cavity, in association with manual maceration of the organ. There were no surgical complications.

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Fig. 5. Incision in the abdominal region for single-port LESS.

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surgical procedures, such as NOTES and LESS, would not have been possible without the painstaking efforts of researchers. After performing laparoscopic surgeries for over two decades, surgeons have developed surgical expertise in laparoscopic methods, learning several lessons that can be applied to LESS. However, the transition to LESS should be different than that from open surgery to laparoscopy, when there was a paradigm shift not only for patients, but also for surgeons.7 Conventional laparoscopy, as well as open surgery, was taught using the Halstedian apprenticeship model of ‘‘see one, do one, teach one’’.21 However, both LESS and NOTES require that professionals partner together, underscoring the need for appropriate training of not only the surgeon, but also the whole team. The success of both open surgery and conventional laparoscopy depends largely on an experienced surgeon who guides the assistants and, particularly in open surgery, controls the surgery almost completely. With the introduction of laparoscopy, the surgeon has lost part of this control, having to rely, at least in part, on an assistant with in-depth knowledge of surgery. In advanced minimally invasive procedures such as LESS this dependence is outstanding, since maximum accuracy and coordination is required from both the surgeon and assistants. Anatomy and the surgical plan must be fully understood by the whole team, justifying the investment in adequate and continuous training for this technique. In view of the foregoing, the authors described five different surgical procedures that might be used as part of a training program for this technique. The authors also considered, in the five models proposed, the existence of different degrees of difficulty associated with the use or not of intracorporeal sutures, which already represent some difficulty for laparoscopic surgeries, and become even more difficult when performed by LESS. The authors believe that continuous training is essential to achieve proficiency levels and to evaluate possible peculiarities, difficulties and applications before the technique can be tried on human subjects. The authors also emphasize that the number of surgeries performed in this study is not sufficient to achieve proficiency in the method. Training on an animal model proved that all the procedures herein proposed are feasible. Some factors, however, should be evaluated before choosing a procedure using single incision or devices that allow transparietal single access. For instance, the use of flexible instrumentation can minimize or even resolve the collision problem observed in LESS. The single-incision procedure proved to be less difficult to perform than the single-port procedure, since the first enables a wider range of movement, although small when compared to conventional laparoscopic surgery. Regardless of performing a single-incision or single-port procedure, LESS surgery requires restricted movements and, therefore, the team needs to partner together, reinforcing the need for prior training of a group of surgeons to ultimately achieve a high rate of success. In addition to an experienced laparoscopic surgeon, team training could enhance the performance of LESS, as well as help the team to adapt to the peculiarities of this technique. Therefore, the authors suggest the following training plan for LESS:

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4. Discussion

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The advances in medical and surgical practice have opened new frontiers, leading to rapid technology development, and new

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1. LESS must be performed only by experienced laparoscopic surgeons, with a complete and experienced surgical team; 2. The operation must focus on the primary procedure, thus minimizing the risk of unexpected injuries, especially due to the lower range of movement allowed by this technique; 3. In LESS ‘‘the great is enemy of the good’’ (the camera assistant is affected by instrumentation collision and vision is often peripheral, but, if vision is considered safe, it is allowed in LESS); 4. There must be a safety plan prior to surgery, including conversion to laparoscopic surgery or even to open surgery in the case of complications; 5. LESS should be gradually implemented in medical residency programs.

564 565 566 567 568 569 570 571 572 573 Conflict of interest 574 None to declare. 575 Funding 576 We used personal resources in this research. 577 578 Ethical approval 579 The completion of the procedures followed all the care proposed by 580 the Brazilian College of Animal Experimentation (COBEA). 581 582 References Q2 583 584 1. Flora ED, et al. A review of natural orifice translumenal endoscopic surgery (NOTES) for Intra-abdominal surgery. Ann Surg 2008;247(4):583–602. Q3 585 2. Harrell AG, Heniford BT. Minimally invasive abdominal surgery: lux et veritas 586 past, present, and future. Am J Surg 2005;190(2):239–43. 587 3. Ellison EC, Carey LC. Lessons learned from the evolution of the laparoscopic 588 revolution. Surg Clin N Am 2008;88:927–41. 4. Cavazzola LT. Laparoendoscopic single site surgery (LESS) – Is it a bridge to 589 natural orifice translumenal endoscopic surgery (NOTES) or the final 590 evolution of minimally invasive surgery? Braz J Videoendoscopic Surg 591 2008;1(3):94–5. 592 5. Gadacz TR, Talamini MA. Traditional versus laparoscopic cholecystectomy. Am J Surg 1991;161(3):336–8. 593 6. Tacchino R, Greco F, Matera D. Single-incision laparoscopic cholecystectomy: 594 surgery without a visible scar. Surg Endosc 2009;23:896–9. 595 7. Mintz Y, Talamini MA, John Cullen J. Evolution of laparoscopic surgery: lessons for NOTES. Gastrointest Endosc Clin N Am 2008;18:225–34. 596 8. Piskun G, Rajpal S. Transumbilical laparoscopic cholecystectomy utilizes no 597 incisions outside the umbilicus. J Laparoendosc Adv Surg Tech A 2008;9(4): 598 361–4. 9. Gettman MT, Lotan Y, Napper CA, Cadeddu JA. Transvaginal laparoscopic 599 nephrectomy: development and feasibility in the porcine model. Urology 600 2002;59:446–50. 601 10. Kalloo AN, Singh VK, Jagannath SB, Niiyama H, Hill SL, Vaughn CA, et al. Flexible transgastric peritoneoscopy: a novel approach to diagnostic and therapeutic 602 interventions in the peritoneal cavity. Gastrointest Endosc 2004;60:114–7. 603 11. Kim YS, Kim CY, Chun HJ. Natural orifice transluminal endoscopic surgery 604 (NOTES). Korean J Gastroenterol 2008;51(3):154–8. 12. Nguyen NT, et al. Laparoscopic transumbilical cholecystectomy without visible 605 abdominal scars. J Gastrointest Surg 2009;13:1125–8. 606 13. Savaris RF, Cavazzola LT. Ectopic pregnancy: laparoendoscopic single-site 607 surgery – laparoscopic surgery through a single cutaneous incision. 1170. Fertil 608 Steril 2009;92(3):e5–7 [Epub 2009 Jul 15]. 14. Ponsky TA, Diluciano J, Chwals W, et al. Early experience with single-port 609 laparoscopic surgery in children. J Laparoendosc Adv Surg Tech 2009;19(4). 610 15. Cuesta MA. The ‘‘invisible cholecystectomy’’: a transumbilical laparoscopic 611 operation without a scar. BF (18 de Outubro de 2007). Surg Endosc 2008;22(5):1211–3. 612 16. Saber AA, et al. Single incision laparoscopic Sleeve Gastrectomy (SILS): a novel 613 technique. Obes Surg 2008;18(10):1338–42. 614 17. Gill IS and LESS Consortium. Consensus statement on the consortium for Laparoendoscopic Single Site (LESS) Surgery. Ann Surg. IN: Sotelo R, et al. 615 ´ gicas Laparoendoscopic single-site surgery (less): initial experience. Actas Urolo 616 õlas, 33(2):172–181, in press Espan 617 18. Box G, et al. Nomenclature of natural orifice translumenal endoscopic surgery (NOTESÔ) and laparoendoscopic single-site surgery (LESS) procedures in 618 Urology. November. J Endourol 2008;22(11):2575–81. 619 19. Hodgett SE, Hernandez JM, Morton CA, Ross SB, Albrink M, Rosemurgy AS. 620 Laparoendoscopic single site (LESS) cholecystectomy. J Gastrointest Surg 2009;13:188–92. 621 20. Levy LC, Adrales G, Rothstein RI. Training for NOTES. Gastrointest Endosc Clin N 622 Am 2008;18:343–60. 623 21. Al-Akash M, Boyle E, Tanner WA. Training on N.O.T.E.S.: from history we learn. 624 Surg Oncol 2009;18:111–9. 625 626

Additionally, it is essential to emphasize that:

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As a result, with proper training, LESS may become the procedure of choice for several surgeries. However, further investigation is warranted to clarify certain aspects and outcomes of this technique, as well as to compare them to those from other surgical methods. For technique development and advances in LESS surgery and training, support from the medical industry is of utmost importance, in order to improve instrumentation and make them available during training. Finally, we should not repeat the same mistake that such legends of medicine as Jean Nicolas Marjolin made, when in 1828 he stated that: ‘‘Surgery has reached such level of refinement that we cannot wait for any improvement.’’ Instead, we have to analyze with critical sense our desire for a less invasive approach that might translate into a benefit to our patients and might also enable us to safely define the best approach to be used in each case. 5. Conclusion

LESS procedures are feasible and should be exhaustively trained before their inclusion in human procedures. LESS procedures can be considered as further refinements in laparoscopic techniques; however, there are some peculiarities and difficulties inherent in this procedure, such as: maximum accuracy and coordination is required from the surgeon and assistants; difficulty, and sometimes

impossibility, of centering surgical instruments on the screen; lower range of movement; among others. These and other aspects mentioned in this study impose a need for a training program for LESS combining theory and practice prior to its use in human subjects. This training is essential to achieve proﬁciency levels so that the technique (with proper training) can beneﬁt patients in the future, becoming the technique of choice for minimally invasive procedures.

f. Conversion plan in the case of complications; g. Difficulty, and sometimes impossibility, of centering the clamps on the screen; h. Surgical wound complications – theoretical possibility that a larger incision may increase the risk of infection and incisional hernia. 2. Practical aspects: a. Use of simulators; b. Extensive training on animal models, after achieving proficiency in simulators; c. Team training on instrument handling; d. Training on restricted movements; e. Use of flexible instrumentation; f. Work with experienced surgeons in LESS as a camera assistant before performing any procedure of this nature; g. In the first LESS procedures, to be accompanied by a surgeon experienced in the method; h. Always work with a team largely familiar with the method.

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