EinsteinVision_fordeler ved bruk av 3D

I dette dokumentet finner du interessante vurderinger av 3D i to vitenskapelige studier fra EAES og S.I.C.E Hvis du har spørsmål om 3D eller vårt 3D-system Einstein Vision 3.0 så ta gjerne kontakt med oss.

Recommendations/suggestions by EAES* and S.I.C.E.*

Non-robotic 3D vs. 2D laparoscopic general surgery EAES Consensus Conference 20181

EAES recommends 3D to reduce lap

operative time significantly (mean

S.I.C.E. 2018 HTA* report2

3D reduces

operative median

time by 21.94%.

difference of 11 min.).

Reduced operative time in right colectomy, hiatal hernia and mini gastric

3D system leads to economic saving

bypass.

of €

3D may reduce rate of complica-

3D could be considered the norm

3D improves

Novice surgeons perform

tions (particularly involving suturing).

outcomes for junior

trainees.

3D may decrease

workload.

cognitive

255.035 over 1 year period.

public or private healthcare.

in

difficult

tasks more easily with 3D.

3D provides significant

differ-

ences in depth perception and eye-hand

1

Arezzo A et al. The use of 3D laparoscopic imaging systems in surgery: EAES consensus development conference 2018. Surg Endosc 2018.

DOI: 10.1007/s00464-018-06612-x

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Vettoretto N et al. Why laparoscopists may opt for three-dimensional view: a summary of the full HTA report on 3D versus 2D Laparoscopy by S.I.C.E. (Società Italiana de Chirurgia Endoscopia e Nuove Tecnologie). Surg Endosc 2018 (32):2986-93. DOI: 10.1007/s00464-017-6006-y

*

EAES = Endoscopic Association for Endoscopic Surgery; S.I.C.E. = Società Italiana de Chirurgia Endoscopia e Nuove Tecnologie; HTA = Health Technology Assessment

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coordination.

Author's personal copy Surgical Endoscopy https://doi.org/10.1007/s00464-018-06612-x

and Other Interventional Techniques

The use of 3D laparoscopic imaging systems in surgery: EAES consensus development conference 2018 Alberto Arezzo1 · Nereo Vettoretto2 · Nader K. Francis3 · Marco Augusto Bonino1 · Nathan J. Curtis3,4 · Daniele Amparore5 · Simone Arolfo1 · Manuel Barberio6 · Luigi Boni7 · Ronit Brodie8 · Nicole Bouvy9 · Elisa Cassinotti7 · Thomas Carus10 · Enrico Checcucci5 · Petra Custers9 · Michele Diana6 · Marilou Jansen11 · Joris Jaspers12 · Gadi Marom8 · Kota Momose13 · Beat P. Müller-Stich14 · Kyokazu Nakajima13 · Felix Nickel14 · Silvana Perretta6 · Francesco Porpiglia5 · Francisco Sánchez-Margallo15 · Juan A. Sánchez-Margallo15 · Marlies Schijven11 · Gianfranco Silecchia16 · Roberto Passera1 · Yoav Mintz8 Received: 18 August 2018 / Accepted: 27 November 2018 © Springer Science+Business Media, LLC, part of Springer Nature 2018

Abstract Background The use of 3D laparoscopic systems is expanding. The European Association of Endoscopic Surgery (EAES) initiated a consensus development conference with the aim of creating evidence-based statements and recommendations for the surgical community.

Methods Systematic reviews of the PubMed and Embase libraries were performed to identify evidence on potential benefits of 3D on clinical practice and patient outcomes. Statements and recommendations were prepared and unanimously agreed by an international surgical and engineering expert panel which were presented and voted at the EAES annual congress, London, May 2018.

Results 9967 abstracts were screened with 138 articles included. 18 statements and two recommendations were generated and approved. 3D significantly shortened operative time (mean difference 11 min (8% [95% CI 20.29–1.72], I2 96%)). A significant reduction in complications was observed when 3D systems were used (RR 0.75, [95 CI% 0.60–0.94], I2 0%) particularly for cases involving laparoscopic suturing (RR 0.57 [95% CI 0.35–0.90], I2 0%). In 69 box trainer or simulator studies, 64% concluded trainees were significant faster and 62% performed fewer errors when using 3D. Conclusion We recommend the use of 3D vision in laparoscopy to reduce the operative time (grade of recommendation: low). Future robust clinical research is required to specifically investigate the potential benefit of 3D laparoscopy system on complication rates (grade of recommendation: high).

Keywords 3D laparoscopy · 3D vision · Three-dimensional · Imaging · Laparoscopic · Consensus Stereopsis is the perception of depth that arises from comparison of disparities in the images projected to two laterally separated eyes [1]. Most surgeons (except those who lack depth perception) use this visual effect in open surgery. Conventional two-dimensional (2D) minimally invasive surgery (MIS) using single-channel endoscopes and 2D screens is akin to monocular viewing.

Contemporary 3D MIS systems capture separate images using dual-channel laparoscopes consisting of either two separate rod lenses or two separate chips at the end of the * Alberto Arezzo alberto.arezzo@unito.it Extended author information available on the last page of the article

scope to provide two vertically separated images. This produces different fixed distance perspectives of the operative field and simulates binocular imaging as if the viewer were positioned at the tip of the laparoscope [2]. In most modern commercially available 3D systems, users wear lightweight glasses that polarize alternate horizontal rows of pixels corresponding to the right- and left-eye images.

The first randomized controlled trial (RCT) investigating three-dimensional imaging was reported 20 years ago [3].

This used a now outdated system as technological developments have led to improved system quality and overcome many of the technical and resolution challenges seen in early platforms. Several studies have been published in recent years, both in experimental and clinical settings, suggesting

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3D systems present a number of potential benefits to surgeons, trainees and patients [4]. Therefore, the European Association of Endoscopic Surgery (EAES) sponsored this consensus development conference on the use of 3D laparoscopy MIS systems. The aim of this consensus was to draw a number of statements based on the available evidence and develop recommendations for the MIS surgical community.

Research team

Materials and methods The scope of this consensus on the use of 3D systems in laparoscopic surgery consisted of three main parts: general topics, organ-specific data and ongoing trials. The coordinating team (AA, YM and NV) formulated a list of questions related to each topic to be specifically addressed, which guided literature searches (Table 1) conducted in cooperation with a medical information specialist of the University of Torino. An initial literature search was conducted in order to identify any additional topics of interest.

All searches were performed in both PubMed and Embase electronic libraries on 22 September 2017 with no limitation regarding year of publication or language. Search strings are displayed in Table 2. Study inclusion criteria were (a) trials on 3D technology in the selected topic (Table 2); (b) RCTs, prospective and retrospective observational comparative studies. Case reports or series of less than 10 patients were excluded.

Endpoints The two primary endpoints were the impact of 3D on operative time and complications (both intra- and post-operative).

Eligible organ-specific studies were also merged into a single Table 1 List of questions regarding the use of 3D to be addressed

1 1.1 1.2 1.3 2 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 2.10 2.11

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dataset for operative time assessment in addition to separate subgroup analyses. Complications were analysed together and also underwent planned subgroup analysis where only those that appeared directly related to surgery were included.

RCTs and prospective studies were used for the analysis of all outcomes but complications also included data retrieved from retrospective studies.

The coordinators invited 13 surgeons and engineering members of the EAES executive and technology committee with recognized expertise on the topic of 3D vision to join the panel of experts. Each was asked to nominate at least one young surgical researcher to participate. An international research team of 14 young surgical researchers was formed to review and evaluate the existing literature on the use of 3D technology in laparoscopy. Young researchers were mentored by a senior expert. The final list of topics was approved by the experts and subsequently divided among the teams (Table 3).

All search hits were screened by topic and reviewed by two team members for eligibility, based on title and abstract.

If considered eligible, full-text articles were reviewed and summarized. In cases of disagreement, the coordinators acted as referee and made the final decision. Standardized data extraction forms were used across all topics. A PRISMA chart was completed for each literature search according to recommendations [5]. The methodological quality of included RCT was assessed using the Cochrane risk of bias score [6]. All included studies were evaluated with the GRADE system [7–9]. GRADE is a systematic and explicit approach to judging quality of evidence and strength of recommendations. GRADE specifically assesses

General topics Does 3D vision improve outcomes in box trainer tasks?

Does 3D vision introduce a higher cognitive load for the surgeon compared to standard laparoscopic systems?

What is the impact of 3D vision on costs?

Organ specific What is the impact of 3D vision on operating time?

What is the impact of 3D vision on complications?

What is the impact of 3D vision in laparoscopic cholecystectomy?

What is the impact of 3D vision in colorectal surgery?

What is the impact of 3D vision in upper GI surgery for benign diseases?

What is the impact of 3D vision in upper GI cancer surgery?

What is the impact of 3D vision in bariatric surgery?

What is the impact of 3D vision in liver, pancreas, spleen and adrenal surgery?

What is the impact of 3D vision in abdominal wall surgery?

What is the impact of 3D vision in gynecologic surgery?

What is the impact of 3D vision in urologic surgery?

Pubmed

General Topics Impact on basic laparoscopy (“Imaging, Three-Dimensional”[Mesh] OR 3D OR 3-D OR three-dimension* OR 3-dimension*) AND (“Laparoscopy”[Mesh] OR “Laparoscopes”[Mesh] OR laparosc* OR laparoendosc* OR celioscop* OR “Minimally Invasive Surgical Procedures” [Mesh:NoExp] OR minimally-invasive-surg*) AND (equipm*[title] OR instrument*[title] OR methods*[title] OR methodol*[title] OR standard*[title] OR basic*[title] OR techniq*[title] OR technic*[title] OR technologi*[title] OR principles[title] OR practices[title] OR advances[title]) Training (“Imaging, Three-Dimensional”[Mesh] OR 3D OR 3-D OR three-dimension* OR 3-dimension*) AND (“Laparoscopy”[Mesh] OR “Laparoscopes”[Mesh] OR laparosc* OR laparoendosc* OR celioscop* OR “Minimally Invasive Surgical Procedures”[Mesh:NoExp] OR minimally-invasive-surg*) AND (“Education”[Mesh] OR education[sh] OR educat* OR train* OR teach*) Cognitive load (“Imaging, Three-Dimensional”[Mesh] OR 3D OR 3-D OR three-dimension* OR 3-dimension*) AND (“Laparoscopy”[Mesh] OR “Laparoscopes”[Mesh] OR laparosc* OR laparoendosc* OR celioscop* OR “Minimally Invasive Surgical Procedures”[Mesh:NoExp] OR minimally-invasive-surg*) AND (“Cognition”[Mesh] OR “Learning”[Mesh] OR “Task performance and Analysis”[Mesh] OR cognitive-load* OR workload* OR working-load* OR work-load* OR task* OR learn* OR memor* OR effort* OR instruction* OR skill*[title] OR competenc*[title] OR proficien*[title] OR performance*[title]) Pitfalls (“Imaging, Three-Dimensional”[Mesh] OR 3D OR 3-D OR three-dimension* OR 3-dimension*) AND (“Laparoscopy”[Mesh] OR “Laparoscopes”[Mesh] OR laparosc* OR laparoendosc* OR celioscop* OR “Minimally Invasive Surgical Procedures”[Mesh:NoExp] OR minimally-invasive-surg*) AND (“Intraoperative Complications”[Mesh] OR “adverse effects”[sh] OR pitfall*[title] OR hazard*[title] OR failure*[title] OR complicat*[title] OR adverse[title] OR difficult*[title] OR disadvantag*[title]) Costs and cost/effectiveness (“Imaging, Three-Dimensional”[Mesh] OR 3D OR 3-D OR three-dimension* OR 3-dimension*) AND (“Laparoscopy”[Mesh] OR “Laparoscopes”[Mesh] OR laparosc* OR laparoendosc* OR celioscop* OR “Minimally Invasive Surgical Procedures”[Mesh:NoExp] OR minimally-invasive-surg*) AND (“Costs and Cost Analysis” [mesh] OR cost OR costs OR economics[sh] OR econom* OR cost-effect* OR cost-benef* OR cost-util*) Organ specific Cholecystectomy (“Imaging, Three-Dimensional”[Mesh] OR 3D OR 3-D OR three-dimension* OR 3-dimension*) AND (“Laparoscopy”[Mesh] OR “Laparoscopes“[Mesh] OR laparosc* OR laparoendosc* OR celioscop* OR “Minimally Invasive Surgical Procedures” [Mesh:NoExp] OR minimally-invasive-surg*) AND (“Gallbladder”[Mesh] OR “Gallbladder Diseases”[Mesh] OR “Cholecystectomy”[Mesh] OR cholecyst* OR gallbladder* OR gall-bladder* OR gallstone* OR gall-stone*)

Table 2 Literature searches

(‘three dimensional imaging’/exp OR 3d OR ‘3 d’ OR ‘three dimension*’ OR ‘3 dimension*’) AND (‘laparoscopy’/exp OR ‘laparoscope’/exp OR laparosc* OR laparoendosc* OR celioscop* OR ‘minimally invasive surgery’/de OR ‘minimally invasive surg*’) AND (‘gallbladder’/exp OR ‘gallbladder disease’/ exp OR ‘cholecystectomy’/exp OR cholecyst* OR gallbladder* OR ‘gall bladder*’ OR gallstone* OR ‘gall stone*’)

(‘three dimensional imaging’/exp OR 3d OR ‘3 d’ OR ‘three dimension*’ OR ‘3 dimension*’) AND (‘laparoscopy’/exp OR ‘laparoscope’/exp OR laparosc* OR laparoendosc* OR celioscop* OR ‘minimally invasive surgery’/de OR ‘minimally invasive surg*’) AND (‘cost’/exp OR ‘health economics’/exp OR cost OR costs OR econom* OR cost-effect* OR cost-benef* OR cost-util*)

(‘three dimensional imaging’/exp OR 3d OR ‘3 d’ OR ‘three dimension*’ OR ‘3 dimension*’) AND (‘laparoscopy’/exp OR ‘laparoscope’/exp OR laparosc* OR laparoendosc* OR celioscop* OR ‘minimally invasive surgery’/de OR ‘minimally invasive surg*’) AND (‘peroperative complication’/exp OR pitfall*:ti OR hazard*:ti OR failure*:ti OR complicat*:ti OR adverse:ti OR difficult*:ti OR disadvantag*:ti)

(‘three dimensional imaging’/exp OR 3d OR ‘3 d’ OR ‘three dimension*’ OR ‘3 dimension*’) AND (‘laparoscopy’/exp OR ‘laparoscope’/exp OR laparosc* OR laparoendosc* OR celioscop* OR ‘minimally invasive surgery’/de OR ‘minimally invasive surg*’) AND (‘education’/exp OR educat* OR train* OR teach*) (‘three dimensional imaging’/exp OR 3d OR ‘3 d’ OR ‘three dimension*’ OR ‘3 dimension*’) AND (‘laparoscopy’/exp OR ‘laparoscope’/exp OR laparosc* OR laparoendosc* OR celioscop* OR ‘minimally invasive surgery’/de OR ‘minimally invasive surg*’) AND (‘cognition’/exp OR ‘learning’/exp OR ‘task performance’/exp OR cognitive-load* OR workload* OR working-load* OR work-load* OR task* OR learn* OR memor* OR effort* OR instruction* OR skill*:ti OR competenc*:ti OR proficien*:ti OR performance*:ti)

(‘three dimensional imaging’/exp OR 3d OR ‘3 d’ OR ‘three dimension*’ OR ‘3 dimension*’) AND (‘laparoscopy’/exp OR ‘laparoscope’/exp OR laparosc* OR laparoendosc* OR celioscop* OR ‘minimally invasive surgery’/ de OR ‘minimally invasive surg*’) AND (equipm*:ti OR instrument*:ti OR methods*:ti OR methodol*:ti OR standard*:ti OR basic*:ti OR techniq*:ti OR technic*:ti OR technologi*:ti OR principles:ti OR practices:ti OR advances:ti)

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Adrenal

Spleen

Bariatrics

Colon and rectum

Appendectomy

Table 2 (continued)

(“Imaging, Three-Dimensional”[Mesh] OR 3D OR 3-D OR three-dimension* OR 3-dimension*) AND (“Laparoscopy”[Mesh] OR “Laparoscopes”[Mesh] OR laparosc* OR laparoendosc* OR celioscop* OR “Minimally Invasive Surgical Procedures”[Mesh:NoExp] OR minimally-invasive-surg*) AND (“Appendix”[Mesh] OR “Appendiceal Neoplasms” [Mesh] OR “Appendectomy”[Mesh] OR “Appendicitis”[Mesh] OR append*) (“Imaging, Three-Dimensional”[Mesh] OR 3D OR 3-D OR three-dimension* OR 3-dimension*) AND (“Laparoscopy”[Mesh] OR “Laparoscopes”[Mesh] OR laparosc* OR laparoendosc* OR celioscop* OR “Minimally Invasive Surgical Procedures” [Mesh:NoExp] OR minimally-invasive-surg*) AND (“Colon”[Mesh] OR “Colonic Diseases”[Mesh] OR “Rectum”[Mesh] OR “Rectal Diseases”[Mesh] OR “Colorectal Surgery”[Mesh] OR “Anal Canal”[Mesh] OR “Colectomy”[Mesh] OR “Ileostomy”[Mesh] OR “Colostomy”[Mesh] OR colon OR colonic* OR colectom* OR ileostom* OR colostom* OR polypect* OR rectum* OR rectal* OR colorect* OR colorect* OR polyposis-coli OR sigmoid* OR anus OR anal) (“Imaging, Three-Dimensional”[Mesh] OR 3D OR 3-D OR three-dimension* OR 3-dimension*) AND (“Laparoscopy”[Mesh] OR “Laparoscopes”[Mesh] OR laparosc* OR laparoendosc* OR celioscop* OR “Minimally Invasive Surgical Procedures” [Mesh:NoExp] OR minimally-invasive-surg*) AND (“Bariatric Surgery”[Mesh] OR “Obesity, Morbid”[Mesh] OR “Gastric Balloon”[Mesh] OR obes* OR bariatr* OR weight-loss-surg* OR metabolicsurg* OR biliopancreatic-diver* OR bilio-pancreatic-diver* OR gastroplast* OR stomach-stapl* OR gastric-band* OR sleeve-gastrectom* OR gastricsleeve* OR intragastric-balloon* OR gastric-balloon* OR gastric-bypass* OR jejunoileal-bypass* OR jejuno-ileal-bypass* OR intestinal-bypass*) (“Imaging, Three-Dimensional”[Mesh] OR 3D OR 3-D OR three-dimension* OR 3-dimension*) AND (“Laparoscopy”[Mesh] OR “Laparoscopes”[Mesh] OR laparosc* OR laparoendosc* OR celioscop* OR “Minimally Invasive Surgical Procedures” [Mesh:NoExp] OR minimally-invasive-surg*) AND (“Spleen”[Mesh] OR “Splenic Diseases”[Mesh] OR “Splenectomy”[Mesh] OR spleen* OR splenic* OR splenect*) (“Imaging, Three-Dimensional”[Mesh] OR 3D OR 3-D OR three-dimension* OR 3-dimension*) AND (“Laparoscopy”[Mesh] OR “Laparoscopes”[Mesh] OR laparosc* OR laparoendosc* OR celioscop* OR “Minimally Invasive Surgical Procedures” [Mesh:NoExp] OR minimally-invasive-surg*) AND (“Adrenal Glands”[Mesh] OR “Adrenal Gland Diseases”[Mesh] OR “Adrenalectomy”[Mesh] OR adrenal* OR adrenocortic* OR adreno-cortic* OR adrenal-cortic*)

Pubmed

(‘three dimensional imaging’/exp OR 3d OR ‘3 d’ OR ‘three dimension*’ OR ‘3 dimension*’) AND (‘laparoscopy’/exp OR ‘laparoscope’/exp OR laparosc* OR laparoendosc* OR celioscop* OR ‘minimally invasive surgery’/de OR ‘minimally invasive surg*’) AND (‘adrenal gland’/exp OR ‘adrenal disease’/ exp OR ‘adrenalectomy’/exp OR adrenal* OR adrenocortic* OR ‘adreno cortic*’ OR ‘adrenal cortic*’)

(‘three dimensional imaging’/exp OR 3d OR ‘3 d’ OR ‘three dimension*’ OR ‘3 dimension*’) AND (‘laparoscopy’/exp OR ‘laparoscope’/exp OR laparosc* OR laparoendosc* OR celioscop* OR ‘minimally invasive surgery’/ de OR ‘minimally invasive surg*’) AND (‘bariatric surgery’/exp OR ‘morbid obesity’/exp OR ‘gastric balloon’/exp OR obes* OR bariatr* OR ‘weight loss surg*’ OR ‘metabolic surg*’ OR ‘biliopancreatic diver*’ OR ‘bilio pancreatic diver*’ OR gastroplast* OR ‘stomach stapl*’ OR ‘gastric band*’ OR ‘sleeve gastrectom*’ OR ‘gastric sleeve*’ OR ‘intragastric balloon*’ OR ‘gastric balloon*’ OR ‘gastric bypass*’ OR ‘jejunoileal bypass*’ OR ‘jejuno ileal bypass*’ OR ‘intestinal bypass*’) (‘three dimensional imaging’/exp OR 3d OR ‘3 d’ OR ‘three dimension*’ OR ‘3 dimension*’) AND (‘laparoscopy’/exp OR ‘laparoscope’/exp OR laparosc* OR laparoendosc* OR celioscop* OR ‘minimally invasive surgery’/de OR ‘minimally invasive surg*’) AND (‘spleen’/exp OR ‘spleen disease’/exp OR ‘spleen surgery’/exp OR spleen* OR splenic* OR splenect*)

(‘three dimensional imaging’/exp OR 3d OR ‘3 d’ OR ‘three dimension*’ OR ‘3 dimension*’) AND (‘laparoscopy’/exp OR ‘laparoscope’/exp OR laparosc* OR laparoendosc* OR celioscop* OR ‘minimally invasive surgery’/de OR ‘minimally invasive surg*’) AND (‘colon’/exp OR ‘colon disease’/exp OR ‘rectum’/exp OR ‘rectum disease’/exp OR ‘anus’/exp OR ‘colorectal surgery’/ exp OR ‘colon surgery’/exp OR ‘ileostomy’/exp OR ‘rectum surgery’/exp OR colon OR colonic* OR colectom* OR ileostom* OR colostom* OR polypect* OR rectum* OR rectal* OR colorect* OR ‘colo rect*’ OR ‘polyposis coli’ OR sigmoid* OR anus OR anal)

(‘three dimensional imaging’/exp OR 3d OR ‘3 d’ OR ‘three dimension*’ OR ‘3 dimension*’) AND (‘laparoscopy’/exp OR ‘laparoscope’/exp OR laparosc* OR laparoendosc* OR celioscop* OR ‘minimally invasive surgery’/de OR ‘minimally invasive surg*’) AND (‘appendix’/exp OR ‘appendix disease’/exp OR ‘appendectomy’/exp OR append*)

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Abdominal Wall

Upper GI malignant

Upper GI benign

Pancreas

Liver

Table 2 (continued) Embase

(“Imaging, Three-Dimensional”[Mesh] OR 3D OR 3-D OR three-dimension* (‘three dimensional imaging’/exp OR 3d OR ‘3 d’ OR ‘three dimension*’ OR ‘3 dimension*’) AND (‘laparoscopy’/exp OR ‘laparoscope’/exp OR laparosc* OR 3-dimension*) AND (“Laparoscopy”[Mesh] OR “Laparoscopes”[Mesh] OR laparoendosc* OR celioscop* OR ‘minimally invasive surgery’/de OR OR laparosc* OR laparoendosc* OR celioscop* OR “Minimally Invasive ‘minimally invasive surg*’) AND (‘liver’/exp OR ‘liver disease’/exp OR ‘liver Surgical Procedures” [Mesh:NoExp] OR minimally-invasive-surg*) AND surgery’/exp OR liver* OR hepatic* OR hepatocel* OR hepatect*) (“Liver”[Mesh] OR “Liver Diseases”[Mesh] OR “Hepatectomy”[Mesh] OR liver* OR hepatic* OR hepatocel* OR hepatect*) (“Imaging, Three-Dimensional”[Mesh] OR 3D OR 3-D OR three-dimension* (‘three dimensional imaging’/exp OR 3d OR ‘3 d’ OR ‘three dimension*’ OR ‘3 dimension*’) AND (‘laparoscopy’/exp OR ‘laparoscope’/exp OR laparosc* OR 3-dimension*) AND (“Laparoscopy”[Mesh] OR “Laparoscopes”[Mesh] OR laparoendosc* OR celioscop* OR ‘minimally invasive surgery’/de OR OR laparosc* OR laparoendosc* OR celioscop* OR “Minimally Inva‘minimally invasive surg*’) AND (‘pancreas’/exp OR ‘pancreas disease’/exp sive Surgical Procedures” [Mesh:NoExp] OR minimally-invasiveOR ‘pancreas surgery’/exp OR pancreas* OR pancreatic* OR ‘islet cell*’) surg*) AND (“Pancreas”[Mesh] OR “Pancreatic Diseases”[Mesh] OR “Pancreatectomy”[Mesh] OR pancreas* OR pancreatic* OR islet-cell*) (“Imaging, Three-Dimensional”[Mesh] OR 3D OR 3-D OR three-dimension* (‘three dimensional imaging’/exp OR 3d OR ‘3 d’ OR ‘three dimension*’ OR ‘3 dimension*’) AND (‘laparoscopy’/exp OR ‘laparoscope’/exp OR laparosc* OR 3-dimension*) AND (“Laparoscopy”[Mesh] OR “Laparoscopes”[Mesh] OR laparoendosc* OR celioscop* OR ‘minimally invasive surgery’/de OR OR laparosc* OR laparoendosc* OR celioscop* OR “Minimally Invasive ‘minimally invasive surg*’) AND (‘upper gastrointestinal tract’/exp OR ‘stomSurgical Procedures”[Mesh:NoExp] OR minimally-invasive-surg*) AND ach’/exp OR ‘esophagus’/exp OR ‘duodenum’/exp OR ‘upper gastrointestinal (“Upper Gastrointestinal Tract”[Mesh] OR “Esophageal Diseases”[Mesh] disease’/exp OR ‘stomach disease’/exp OR ‘esophagus disease’/exp OR ‘duoOR “Stomach Diseases”[Mesh] OR “Duodenal Diseases”[Mesh] OR denum disease’/exp OR ‘stomach surgery’/exp OR ‘esophagus surgery’/exp esophag* OR oesophag* OR stomach* OR duodeno* OR duodena* OR gasOR ‘duodenum surgery’/exp OR esophag* OR oesophag* OR stomach* OR troesophag* OR gastro-esophag* OR gastro-oesophag* OR duodenogastr* duodeno* OR duodena* OR gastroesophag* OR ‘gastro esophag*’ OR ‘gastro OR duodeno-gastric OR paraesophag* OR paraoesophag* OR hiatal-hernia* oesophag*’ OR duodenogastr* OR ‘duodeno gastric’ OR paraesophag* OR OR hiatus-hernia* OR gastric) NOT (“Esophageal Neoplasms”[Mesh] paraoesophag* OR ‘hiatal hernia*’ OR ‘hiatus hernia*’ OR gastric) NOT OR “Stomach Neoplasms”[Mesh] OR “Duodenal Neoplasms”[Mesh] OR (‘stomach tumor’/exp OR ‘esophagus tumor’/exp OR ‘duodenum tumor’/exp neoplas* OR tumor OR tumors OR tumora* OR tumour OR tumours OR OR neoplas* OR tumor OR tumors OR tumora* OR tumour OR tumours OR tumoura* OR cancer OR cancers OR cancero* OR carcinoma* OR maligtumoura* OR cancer OR cancers OR cancero* OR carcinoma* OR malignan* nan* OR oncol*) OR oncol*) (“Imaging, Three-Dimensional”[Mesh] OR 3D OR 3-D OR three-dimension* (‘three dimensional imaging’/exp OR 3d OR ‘3 d’ OR ‘three dimension*’ OR ‘3 dimension*’) AND (‘laparoscopy’/exp OR ‘laparoscope’/exp OR lapaOR 3-dimension*) AND (“Laparoscopy”[Mesh] OR “Laparoscopes”[Mesh] rosc* OR laparoendosc* OR celioscop* OR ‘minimally invasive surgery’/de OR laparosc* OR laparoendosc* OR celioscop* OR “Minimally Invasive OR ‘minimally invasive surg*’) AND (‘stomach tumor’/exp OR ‘esophagus Surgical Procedures”[Mesh:NoExp] OR minimally-invasive-surg*) AND tumor’/exp OR ‘duodenum tumor’ OR ((‘upper gastrointestinal tract’/exp OR (“Esophageal Neoplasms”[Mesh] OR “Stomach Neoplasms”[Mesh] OR ‘stomach’/exp OR ‘esophagus’/exp OR ‘duodenum’/exp OR esophag* OR “Duodenal Neoplasms” [Mesh] OR ((“Upper Gastrointestinal Tract”[Mesh] oesophag* OR stomach* OR duodeno* OR duodena* OR gastroesophag* OR OR esophag* OR oesophag* OR stomach* OR duodeno* OR duodena* OR gastro-esophag* OR gastro-oesophag* OR duodenogastr* OR duodeno-gastric gastroesophag* OR gastro-esophag* OR gastro-oesophag* OR duodeOR gastric) AND (neoplas* OR tumor OR tumors OR tumora* OR tumour nogastr* OR duodeno-gastric OR gastric) AND (neoplas* OR tumor OR OR tumours OR tumoura* OR cancer OR cancers OR cancero* OR carcitumors OR tumora* OR tumour OR tumours OR tumoura* OR cancer OR noma* OR malignan* OR oncol*))) cancers OR cancero* OR carcinoma* OR malignan* OR oncol*))) (“Imaging, Three-Dimensional”[Mesh] OR 3D OR 3-D OR three-dimension* (‘three dimensional imaging’/exp OR 3d OR ‘3 d’ OR ‘three dimension*’ OR ‘3 dimension*’) AND (‘laparoscopy’/exp OR ‘laparoscope’/exp OR laparosc* OR 3-dimension*) AND (“Laparoscopy”[Mesh] OR “Laparoscopes”[Mesh] OR laparoendosc* OR celioscop* OR ‘minimally invasive surgery’/de OR OR laparosc* OR laparoendosc* OR celioscop* OR “Minimally Invasive ‘minimally invasive surg*’) AND (‘abdominal wall’/exp OR ‘abdominal wall Surgical Procedures” [Mesh:NoExp] OR minimally-invasive-surg*) AND defect’/exp OR ‘abdominal wall*’ OR ‘inguinal hernia*’ OR ‘ventral hernia*’ (“Abdominal Wall”[Mesh] OR “Hernia, Abdominal”[Mesh] OR abdominalOR ‘incisional hernia*’) wall* OR inguinal-hernia* OR ventral-hernia* OR incisional-hernia*)

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Author's personal copy [(‘three dimensional imaging’/exp OR 3d OR ‘3 d’ OR ‘three dimension*’ OR ‘3 dimension*’) AND (‘laparoscopy’/exp OR ‘laparoscope’/exp OR laparosc* OR laparoendosc* OR celioscop* OR ‘minimally invasive surgery’/de OR ‘minimally invasive surg*’) AND (‘urinary tract’/exp OR ‘male genital system’/exp OR ‘urinary tract disease’/exp OR ‘male genital system disease’/ exp OR ‘urologic surgery’/exp OR urol* OR kidney* OR renal OR nephrect* OR nephropex* OR nephroureter* OR ureter OR ureteral* OR ureterect* OR bladder* OR prostate* OR cystectom* OR varicocele* OR cryptorchid* OR ‘retroperitoneal lymph node*’ OR ‘pelvic lymph node*’)] NOT ‘gynecologic surgery’/exp (‘three dimensional imaging’/exp OR 3d OR ‘3 d’ OR ‘three dimension*’ OR ‘3 dimension*’) AND (‘laparoscopy’/exp OR ‘laparoscope’/exp OR laparosc* OR laparoendosc* OR celioscop* OR ‘minimally invasive surgery’/de OR ‘minimally invasive surg*’) AND (‘female genital system’/exp OR ‘gynecologic disease’/exp OR ‘gynecologic surgery’/exp OR gynecol* OR gynaecol* OR tubes OR tubal OR endometri* OR ovary OR ovaries OR ovarian OR ovaric* OR hysterect* OR uterin* OR pelvic-floor OR myomectom*) (“Imaging, Three-Dimensional”[Mesh] OR 3D OR 3-D OR three-dimension* OR 3-dimension*) AND (“Laparoscopy”[Mesh] OR “Laparoscopes”[Mesh] OR laparosc* OR laparoendosc* OR celioscop* OR “Minimally Invasive Surgical Procedures” [Mesh:NoExp] OR minimally-invasive-surg*) AND (“Urinary Tract”[Mesh] OR “Genitalia, Male”[Mesh] OR “Male Urogenital Diseases”[Mesh] OR “Urologic Diseases”[Mesh] OR “Urologic Surgical Procedures”[Mesh] OR urol* OR kidney* OR renal OR nephrect* OR nephropex* OR nephroureter* OR ureter OR ureteral* OR ureterect* OR bladder* OR prostate* OR cystectom* OR varicocele* OR cryptorchid* OR retroperitoneal-lymph-node* OR pelvic-lymph-node*) (“Imaging, Three-Dimensional”[Mesh] OR 3D OR 3-D OR three-dimension* OR 3-dimension*) AND (“Laparoscopy”[Mesh] OR “Laparoscopes”[Mesh] OR laparosc* OR laparoendosc* OR celioscop* OR “Minimally Invasive Surgical Procedures” [Mesh:NoExp] OR minimally-invasive-surg*) AND (“Genitalia, Female”[Mesh] OR “Female Urogenital Diseases”[Mesh] OR “Gynecologic Surgical Procedures”[Mesh] OR gynecol* OR gynaecol* OR tubes OR tubal OR endometri* OR ovary OR ovaries OR ovarian OR ovaric* OR hysterect* OR uterin* OR pelvic-floor OR myomectom*)

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Gynaecology

Embase Pubmed

Urology

Table 2 (continued)

Surgical Endoscopy

methodological flaws, consistency of results across different studies, generalizability of research results and treatment effectiveness. The original Centre for Evidence-Based Medicine levels of evidence (LoE) system was used [9].

The highest levels of identified evidence were assessed first. If there was a systematic review of sufficient quality, it was used to answer the research question with a statement.

When data were considered sufficient, consensus statements were prepared by each team and scored with a grade of recommendation (GoR).

Consensus development process A face-to-face consensus meeting was held in London on 20 January 2018 to present all findings and drafted consensus statements and recommendations, which were finalized during two further virtual meetings. A modified Delphi method was used, as anonymity was not applicable in our situation [10–12]. All statements and recommendations were shared with the proposed LoE and subjected to voting for agreement or disagreement. In case of 100% consensus, the statements and recommendations were accepted. Where there was lack of consensus, the research team responsible for that topic presented the underlying evidence and rationale for their statement. After discussion, further voting rounds were conducted until an agreement was reached.

All finalized recommendations and statements with LoE and GoR were presented at a dedicated session during the 26th EAES congress London 2018. Fifty delegates attended and voted on each statement in two aspects: (a) Do you agree with the above-mentioned recommendation? (b) Will this recommendation change your practice?

Statistical analyses All analyses were performed by a specialist biostatistician (RP), according to the original treatment allocation (intention-to-treat analysis). For binary outcome data, the relative risk (RR) and 95% confidence interval (CI) were estimated using the Mantel–Haenszel method; a RR < 1 favoured 3D vision. For continuous outcome data, the mean differences (MD) and 95% CI were estimated using inverse variance weighting with negative MD values favouring 3D vision.

When means and/or standard deviation were not reported they were estimated from reported medians, ranges and sample size as described by Hozo [13]. A fixed-effects model was used in all meta-analyses, repeating the same analyses using a random-effects model as described by DerSimonian and Laird [14].

Author's personal copy Surgical Endoscopy Table 3 Topics and distribution among experts and young researches

General topics Impact on basic laparoscopy Training Cognitive load Pitfalls Costs and cost/effectiveness Organ specific Cholecystectomy Appendectomy Colon and rectum Bariatrics Spleen Adrenal Liver Pancreas Upper GI benign Upper GI malignant Abdominal wall Urology Gynaecology

Experts

Young researchers

J Jaspers N Francis, S Perretta M Schijven, J Jaspers M Diana, C Tiu C Tiu, M Diana

M Jansen NJ Courtis M Jansen M Barberio M Barberio

L Boni, F Sanchez-Margallo F Sanchez-Margallo, N Vettoretto A Arezzo, L Boni N Bouvy, Y Mintz T Carus, B Müller-Stich T Carus, B Müller-Stich B Müller-Stich, T Carus B Müller-Stich, T Carus Y Mintz, K Nakajima K Nakajima, Y Mintz Y Mintz, A Arezzo F Porpiglia, A Arezzo F Porpiglia, A Arezzo

E Cassinotti, JA Sanchez-Margallo JA Sanchez-Margallo MA Bonino, E Cassinotti P Custers, G Marom F Nichel F Nichel F Nichel F Nichel R Brodie, K Momose K Momose, A Arolfo A Arolfo, G Marom D Amparore, MA Bonino C Ceccucci, MA Bonino

Risk of bias assessment

General topics

Publication bias was assessed by generating a funnel plot and performing the rank correlation test of funnel plot asymmetry. Heterogeneity was assessed by the I2 measure of inconsistency. Potential sources of heterogeneity were explored by different sensitivity analyses: comparing fixed- versus random-effects models (incorporating heterogeneity by using the random-effect method); checking the results of cumulative (sequentially including studies by date of publication) and influential meta-analyses (calculating pooled estimates by omitting one study at a time) and performing subgroup analyses. All analyses were performed with the R package (v3.5.0 Package Meta, The R Foundation for Statistical Computing, Vienna-A. http:// www.R-project.org) [15] and Review Manager (RevMan 5.3; The Cochrane Collaboration).

The impact of 3D vision on basic laparoscopy

Results The literature searches yielded 9967 hits. In total, 138 articles were included and reviewed in detail to define 13 consensus statements and two recommendations. Nearly all studies presented in this review used dual-channel 3D laparoscopes and HD passive polarizing systems.

Statement: 3D vision improves outcomes for junior trainees performing standardized box trainers tasks using properly setup 3D HD systems and passive polarized glasses (LoE: high).

The evidence behind this statement was derived from 14 studies, of which half were RCTs, comparing outcomes of basic experiments using either 2D or 3D vision systems [16–31]. Most RCTs were well designed. Primarily due to insufficient reporting, selection bias could not be excluded.

Only three studies were considered to have a high randomisation bias risk with three considered to be at low risk of bias for participant blinding and 29% for outcome assessment blinding.

Ten papers focused on specific tasks with all but one demonstrating a significant reduction in errors. In five papers, this was assessed on novices. Seven papers (three studying novices) assessed task completion time with all demonstrating a reduction in operative time with 3D. The primary endpoints of included articles varied from task completion time, quality of task performance, enacted errors and subjective questionnaire assessment of comfort and headache. Some studies also used completely different imaging systems for 2D versus 3D [20, 30]. Few studies standardized specific conditions of 3D setup (monitor height, monitor distance and viewing angle) [27, 29] or

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tested participants for their stereovision abilities which could impact outcomes [28, 29].

Impact of 3D vision on training Statement: The use of 3D imaging systems improves laparoscopic box trainer task completion time and error rate but this benefit has not been studied in clinical practice (LoE moderate).

Evidence from 72 primary studies in 19 countries across four continents supported this statement [3, 19–21, 24, 28–30, 32–96]. Publication dates varied from 1996 to 2017 suggesting that a spectrum of 3D systems were used although 57% of the publications were reported in 2014 onwards. Studies included 2452 participants: 1367 (55.8%) were laparoscopically naïve, primarily medical students, with 644 trainees (26.3% [486 junior (26.3%), senior 186 (7.6%)]) and 404 expert surgeons studied. Primary endpoints were operative time (95.8%), enacted errors (62.5%), taskspecific score (22.2%), instrument path length (13.9%), repetitions performed (5.6%) and instrument movement speed (4.2%).

The vast majority of included studies were single centre and utilized crossover designs where participants completed the same tasks in 2D and 3D. 68 studies (94.4%) were performed in box trainer simulators with three animal experiments (two ex-vivo, one live [91]). Only two studies included operative room performance with both using laparoscopic cholecystectomies [3, 80]. Participants performed an average of three tasks (IQR 2–4, range 1–10). Only 36% of studies used previously validated tasks mainly taken from the Fundamentals of Laparoscopic Surgery (FLS) tasks, McGill Inanimate System for Training and Evaluation of Laparoscopic Skills (MISTELS) or European training in basic laparoscopic urological skills (E-BLUS) systems. The selection of the tasks within each simulation was not fully explained and only three studies assessed all tasks from their chosen program.

Of the 33 identified RCTs, primarily due to insufficient reporting, selection bias could not be excluded [6]. Only 30% of the studies were considered to have a low randomization bias risk, with 15% of studies maintaining allocation concealment. Blinding of participants to imaging modality is challenging although one group had students wear 3D glasses before entering the testing room. Only two studies were assessed as low risk of outcome assessment bias [47, 80]. One reviewed deidentified 2D videos of performance and one used automated tracking technology to record instrument metrics. All other assessments were performed by directly observing performance and therefore not blinded to allocation. The use of laboratory-based studies meant attrition bias was low but inadequate reporting meant that selective reporting and other bias could not be fully assessed.

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Overall compliance with the CONSORT statement was low across all included trials.

Pooling all 145 endpoints from included studies, 3D was significantly better in 90 (62.1%). 3D imaging was associated with a significant reduction in task completion time in 44 of 69 studies (63.8%). In the 45 studies using errors as the primary outcome, 28 (62.2%) observed a significant reduction when using 3D. Task-specific scores were significantly higher in the 3D arm in 56.3% of the 16 studies. Instrument path length, repetitions needed and instrument movement speeds were significantly improved by 3D in 50%, 50% and 100% of studies, respectively. It is noteworthy that both clinical studies did not show any time or error count differences between 2D and 3D modalities. Across all studies and endpoints, 2D was seen to be significantly quicker in two studies only (1.4% of all endpoints).

Impact of 3D vision on cognitive load Statement: 3D laparoscopy does not introduce a higher cognitive workload and may result in decreased experienced cognitive workload provided that the viewing setup is optimal (LoE: moderate).

The systematic search identified 1684 hits with seven eligible for inclusion [3, 27, 52, 55, 68, 91, 97]. Three studies were randomized trials [3, 27, 52]. Only one study was of high quality according to Cochrane risk of bias tool [27].

Buia et al. stated that the perceived cognitive workload in 3D laparoscopy was not higher. This was shared by Lin et al. and Feng et al. [27, 52, 91]. Sakata and colleagues found cognitive workload using 3D laparoscopy was lower provided the viewing setup was optimal [98]. Benefits other than lowering cognitive workload were reported by Foo et al. and Kong et al.; however, they reported no conclusion on cognitive workload [55, 97]. The only adverse effects of 3D vision were reported by Hanna et al. [3] although this used an outdated 3D system [3].

Pitfalls of 3D vision in laparoscopy Statement: 3D systems may increase visual fatigue, discomfort and headaches when setup is not optimal (LoE: moderate).

Out of 481 hits found, only 3 articles were included.

3D laparoscopic systems provide an improved stereoscopic vision which facilitates tasks performance, especially in inexperienced subjects [99]. Nevertheless, signs of visual discomfort, such as headache and visual fatigue, dry eyes or double vision, are reported in all studies [1, 99, 100].

Interestingly Zhou et al. [100] found out that whereas individuals experienced the above-mentioned discomfort symptoms, objective visual functional parameters (distance and

Author's personal copy Surgical Endoscopy

near exophoria and esophoria, fusion range, accommodative convergence/accommodation, and tear film breakup time) did not worsen during 3D laparoscopy. Sakata et al. [1] suggested that looking at the screen from eccentric positions causes variable degrees of double vision, whereas an optimal position results when the centre of the screen is aligned with the eyes of the viewer.

Cost-effectiveness No prospective study or RCT directly investigating the cost of the 3D laparoscopy could be found. Hence, no statement made relating to the cost-effectiveness of 3D systems compared to 2D systems can be made.

Pooled evidence on potential clinical benefits from 3D imaging Operative time Statement: 3D laparoscopy shortens the operative time across all analysed surgical specialities (general surgery, urology and gynaecology) (LoE: high).

We included 18 primary studies, reporting data about operative time, from nine countries across three continents [3, 26, 101–116] (Fig. 1). All but one study was published after 2013 suggesting a relatively limited variability of modern 3D systems were used. Studies included 1729 individuals: 487 (25.5%) solid organ operations; 1289 (74.5%) hollow organ procedures; 875 (50.6%) cases contained laparoscopic suturing while 794 papers (45.9%) did not specify the type of surgery. 647 procedures were general surgical with others consisting of urology and gynaecology procedures. The seven identified RCTs were assessed for bias using the Cochrane risk tool [6] (Table 4). Primarily due to insufficient reporting, selection bias could not be excluded.

All were deemed to have a low randomization bias risk with 57% of studies maintaining allocation concealment. Blinding of participants to imaging modality was not possible. Overall compliance with the CONSORT statement was low.

Pooling data derived from the 18 included studies, and 3D significantly shortened operative time. A mean difference (MD) of 11 min (8% [95%CI 1.72–20.29]) in favour of 3D with a high heterogeneity was seen (I2 96%, Fig. 2).

Similarly, operative time in procedures including laparoscopic suturing a MD of 15 min was seen (11% [95%CI 2.70–27.2], I2 87%, Fig. 3). This effect size was reduced in procedures not including laparoscopic suturing with a MD of 6 min (5% [95%CI 0.11–11.79], I2 80%, Fig. 4) and absent in hollow organ procedures with a MD of 2.7 min (3.8% [95 CI% 2.91–8.33], I2 80%, p = 0.34). The analysis of the operative time in procedures performed on solid organs showed a MD of 21.7 min (14% [95 CI% 6.45–36.94], I2 88%, Fig. 5).

Finally, the analysis of the operative time in procedures performed by general surgeons shows a MD of 7.44 min (4% [95 CI% 0.66–14.23], I2 85%, Fig. 6).

Recommendation: We recommend the use of 3D vision in laparoscopy to reduce the operative time (GoR: Low).

The recommendation was voted by 38 delegates with 36 (95%) agreeing and 44% stating this recommendation was likely to change their practice. 8 (19%) were already using 3D, while 15 (37%) disagreed that this recommendation would influence their practice.

Complications Statement: The pooling of data from different settings seems to suggest a lowering in the overall rate of complications after surgical procedures involving suturing in 3D laparoscopy (LoE: low).

We included 18 primary prospective and retrospective studies from eight countries [26, 101–103, 105, 106, 108–112, 114, 118–123]. The flowchart is described in Fig. 7 with risk of bias reported in Table 5. All studies were published after 2013 suggesting a relatively limited variability of 3D systems used. Studies included 1733 individuals. 12 prospective studies included 1039 patients and six retrospective included 694 patients. 10 papers containing 713 patients regarded procedures including laparoscopic suturing with nine general surgical papers of 958 patients and all others consisting of urology and gynaecology procedures. Not all reported complications were considered for the analysis, as some appeared unrelated to the surgical procedure (Table 6).

Overall compliance with the CONSORT statement was low across all five included RCTs, which were also assessed using the Cochrane risk tool [6]. Due to insufficient reporting, selection bias could not be excluded. All were deemed to have a low randomisation bias with 60% of studies also maintaining allocation concealment. Blinding of surgeons to imaging modality was not possible.

Using data pooled from the 18 included studies, a significant overall reduction complications was observed (RR 0.75, [95 CI% 0.60–0.94], I2 0%). However, no significant difference was observed when considering only general surgical procedures (RR 0.78, 95CI 0.60–1.02, I2 0%). When considering procedures including laparoscopic suturing, 3D showed a significant reduction in complications (RR 0.57 [95 CI% 0.35–0.90], I2 0%, Fig. 8). Omitting one study each time, the RR varied from 0.54 to 0.61 but without any statistically significant variation for the I2, demonstrating that no trial was a potential source of inconsistency. This was also confirmed in a subgroup analysis.

When including only RCTs and prospective studies, the reduction in complications increased (RR 0.50 [95 CI% 0.25–0.97], I2 0, Fig. 9).

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Author's personal copy Surgical Endoscopy

Fig. 1 PRISMA 2009 flow diagram—22 September 2018: operative time. Reproduced with permission from Moher et al. [117]

Table 4 Risk of bias (Cochrane risk tool) for RCTs selected for operative time assessment Selection bias

Ruan [26] Kinoshita et al. [106] Fanfani et al. [109] Leon et al. [114] Lu et al. [112] Hoffman et al. [107] Patankar and Padasalagi [104]

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Random sequence generation

Allocation concealment

Low Low Low Low Low Low Low

Low Unclear Low Low Unclear Low Unclear

Performance bias

Detection bias

Attrition bias

Reporting bias

Other bias

Low Low High Low Low Low Unclear

High High Unclear Unclear Low Low Unclear

Low Low Low Unclear Unclear Low Low

Low Low Low Low Unclear Low Unclear

Unclear Unclear Unclear Unclear Unclear Unclear Unclear

Author's personal copy Surgical Endoscopy

Study

Total Mean

3D

2D

SD Total Mean

SD

Weight Overall operative time

MD

Weight

95%−CI (fixed) (random)

Hanna 1998

30

51.67

5.55

30

52.67

6.67

−1.00

[ −4.10; 2.10]

28.1%

6.8%

Bilgen 2013

11

20.63

5.60

11

30.00

6.03

−9.37 [ −14.23; −4.51]

11.5%

6.7%

Kinoshita 2015

57 150.00

53.00

59 148.00 43.00

2.00 [ −15.60; 19.60]

0.9%

5.5%

Ruan 2015

45

97.50

13.80

45 148.00 43.00

−50.50 [ −63.69; −37.31]

1.6%

6.0%

Kyriazis 2015

11

81.00

20.79

30

75.67 23.75

5.33

[ −9.61; 20.27]

1.2%

5.8%

Curro 2015

40

50.00

14.44

40

43.00

7.00

[ 1.74; 12.26]

9.8%

6.7%

Curro 2015

20

78.00

8.50

20

86.00 10.30

−8.00 [ −13.85; −2.15]

7.9%

6.7%

Dominiguez 2016

31

96.71

49.75

29

67.06 47.43

29.65

[ 5.06; 54.24]

0.4%

4.6%

Fanfani 2016

42 168.00

74.50

48 144.00 83.75

24.00

[ −8.70; 56.70]

0.3%

3.7%

Agrusa 2016

13 110.00

27.50

26 120.00 35.00

−10.00 [ −30.11; 10.11]

0.7%

5.2%

Velayutham 2016

20 225.00 109.00

40 285.00 71.00

−60.00 [−112.59; −7.41]

0.1%

2.1%

Whaba 2016

41

98.00

19.00

81 106.00 16.00

−8.00 [ −14.78; −1.22]

5.9%

6.6%

Raspagliesi 2017

15 176.70

74.60

60 215.90 61.60

−39.20

[ −80.04; 1.64]

0.2%

2.9%

Leon 2017

19

69.90

21.50

17

90.10 19.90

−20.20 [ −33.73; −6.67]

1.5%

6.0%

Hoffman 2017

190

90.00

36.00

190 101.00 36.00

−11.00 [ −18.24; −3.76]

5.2%

6.6%

Lu 2017

115 184.00

36.00

113 178.00 37.00

[ −3.48; 15.48]

3.0%

6.4%

Qiu 2017

37 312.50

52.60

45 356.70 43.80

−44.20 [ −65.44; −22.96]

0.6%

5.0%

Patankar 2017

55 111.18

11.60

53 150.19

−39.01 [ −42.58; −35.44]

21.3%

6.8%

Fixed effect model

8.94

6.00

6.80

937

792

−11.72 [ −13.37; −10.08] 100.0%

Random effects model

−11.01 [ −20.29; −1.72]

Heterogeneity: I 2 = 96%, τ2 = 328.4, p < 0.01

−100

Test for overall effect (fixed effect): z = −13.95 (p < 0.01) Test for overall effect (random effects): z = −2.32 (p = 0.02)

−50

0

50

−−

−−

100.0%

Weight

Weight

100

Fa vo urs 3D Fa vo urs 2D

Fig. 2 ABC

Study

Total Mean

3D

2D

SD Total Mean

SD

Suture operative time

MD

95%−CI (fixed) (random)

Kinoshita 2015

57 150.00 53.00

59 148.00 43.000

2.00 [−15.60; 19.60]

4.9%

11.4%

Ruan 2015

45

97.50 13.80

45 148.00 43.000

−50.50 [−63.69; −37.31]

8.7%

12.7%

8

90.38

9.53

20

[ −3.95; 12.21]

23.1%

14.0%

Curro 2015

10

88.00

8.70

10 100.00 10.200

−12.00 [−20.31; −3.69]

21.9%

13.9%

Fanfani 2016

42 168.00 74.50

48 144.00 83.750

Leon 2017

19

69.90 21.50

17

190

Kyriazis 2015

86.25 10.625

4.13 24.00

[ −8.70; 56.70]

1.4%

7.2%

90.10 19.900

−20.20 [−33.73; −6.67]

8.3%

12.6%

−11.00 [−18.24; −3.76]

90.00 36.00

190 101.00 36.000

28.8%

14.1%

Raspagliesi 2017

15 176.70 74.60

60 215.90 61.600

−39.20

[−80.04; 1.64]

0.9%

5.6%

Patankar 2017

21 121.19 39.60

19 157.68 47.530

−36.49 [−63.76; −9.22]

2.0%

8.6%

Hoffman 2017

Fixed effect model

407

468

−11.55 [−15.44; −7.66] 100.0%

Random effects model Heterogeneity: I 2 = 87%, τ2 = 262.8, p < 0.01

−14.95 [−27.20; −2.70]

Test for overall effect (fixed effect): z = −5.82 (p < 0.01)

−50

0

Test for overall effect (random effects): z = −2.39 (p = 0.02)

Favours 3D Favours 2D

−−

−− 100.0%

50

Fig. 3 DEF

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Study

Total Mean 30 11 10 40 3 13 20 41 115 37 28 6

Hanna 1998 Bilgen 2013 Curro 2015 Curro 2015 Kyriazis 2015 Agrusa 2016 Velayutham 2016 Whaba 2016 Lu 2017 Qiu 2017 Patankar 2017 Patankar 2017 Fixed effect model Random effects model 2

3D SD Total Mean

51.67 5.55 20.63 5.60 68.00 8.10 50.00 14.44 56.00 8.78 110.00 27.50 225.00 109.00 98.00 19.00 184.00 36.00 312.50 52.60 96.79 46.18 143.30 37.29

30 11 10 40 10 26 40 81 113 45 26 8

52.67 30.00 72.00 43.00 54.50 120.00 285.00 106.00 178.00 356.70 139.58 166.88

2D SD

Non−suture operative time

6.67 6.03 10.30 8.94 7.50 35.00 71.00 16.00 37.00 43.80 73.15 60.01

−1.00 −9.37 −4.00 7.00 1.50 −10.00 −60.00 −8.00 6.00 −44.20 −42.79 −23.58

440

354 2

Heterogeneity: I = 80%, τ = 60.2026, p < 0.01 Test for overall effect (fixed effect): z = −2.36 (p = 0.02) Test for overall effect (random effects): z = −2.00 (p = 0.05)

MD

Weight Weight 95%−CI (fixed) (random) [ −4.10; 2.10] [ −14.23; −4.51] [ −12.12; 4.12] [ 1.74; 12.26] [ −9.47; 12.47] [ −30.11; 10.11] [−112.59; −7.41] [ −14.78; −1.22] [ −3.48; 15.48] [ −65.44; −22.96] [ −75.70; −9.88] [ −74.76; 27.60]

42.4% 17.3% 6.2% 14.7% 3.4% 1.0% 0.1% 8.9% 4.5% 0.9% 0.4% 0.2%

14.1% 13.4% 11.5% 13.2% 9.7% 5.4% 1.1% 12.3% 10.6% 5.0% 2.6% 1.2%

−2.43 [ −4.45; −0.41] 100.0% −5.95 [ −11.79; −0.11] −−

−− 100.0%

−100 −50 0 50 100 Fa vours 3D Fa vours 2D

Fig. 4 HIJ

Study Ruan 2015 Kyriazis 2015 Kyriazis 2015 Agrusa 2016 Velayutham 2016 Whaba 2016 Qiu 2017 Patankar 2017 Patankar 2017 Fixed effect model Random effects model

Total Mean 45 3 3 13 20 41 37 28 6 196

3D SD Total Mean

97.50 13.80 56.00 8.78 107.00 5.00 110.00 27.50 225.00 109.00 98.00 19.00 312.50 52.60 96.79 46.18 143.30 37.29

45 10 10 26 40 81 45 26 8

148.00 54.50 101.00 120.00 285.00 106.00 356.70 139.58 166.88

2D SD

Solid organs operative time

43.00 7.50 13.75 35.00 71.00 16.00 43.80 73.15 60.01

−50.50 1.50 6.00 −10.00 −60.00 −8.00 −44.20 −42.79 −23.58

291

Heterogeneity: I 2 = 88%, τ2 = 399.9342, p < 0.01 Test for overall effect (fixed effect): z = −5.06 (p < 0.01) Test for overall effect (random effects): z = −2.79 (p < 0.01)

MD

Weight Weight 95%−CI (fixed) (random) [ −63.69; −37.31] [ −9.47; 12.47] [ −4.23; 16.23] [ −30.11; 10.11] [−112.59; −7.41] [ −14.78; −1.22] [ −65.44; −22.96] [ −75.70; −9.88] [ −74.76; 27.60]

11.1% 16.1% 18.5% 4.8% 0.7% 42.1% 4.3% 1.8% 0.7%

13.6% 14.0% 14.2% 12.0% 5.4% 14.7% 11.7% 8.9% 5.6%

−11.35 [ −15.75; −6.96] 100.0% −21.70 [ −36.94; −6.45] −−

−− 100.0%

−100 −50 0 50 100 Favours 3D Favours 2D

Fig. 5 KLM

Recommendation: Future research is recommended to specifically investigate the potential benefit of the use of 3D laparoscopy system on complication rate (GoR: high).

This recommendation was voted by 45 delegates with 39 (87%) agreeing. 30 (72%) stated this recommendation was likely to change their practice while 6 members disagreed (14%) and 6 members (14%) reported already using 3D systems.

Organ specific Cholecystectomy Statements: There is no evidence that 3D vision is superior or inferior to 2D in laparoscopic cholecystectomy in terms of intra- and post-operative complications (LoE: moderate).

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Less experienced surgeons could benefit from 3D imaging resulting in shorter operative time in laparoscopic cholecystectomy (LoE: low).

We analysed 402 hits. Six studies met inclusion criteria containing 309 elective patients (four prospective studies [80, 116, 125, 126] and two RCTs [3, 115]). Publication dates varied from 1998 to 2017, although 84% were reported from 2013 onwards.

All studies used operative time as their primary endpoint.

Three studies demonstrated a reduction in operative time in favour of 3D [115, 116, 126], but in two studies, this was reported only in novices while no difference was noticed in the expert group. In all studies, the rate of conversion to open cholecystectomy and intra- and post-operative complication rate were not different in 3D. Four studies analysed the error rates during laparoscopic procedures with no significant difference seen [3, 80, 115, 126].

Author's personal copy Surgical Endoscopy

Study

Total Mean

3D

2D

SD Total Mean

SD

Weight MD

Operative time

Weight

95%−CI (fixed) (random)

Hanna 1998

30

51.67

5.55

30

52.67

6.67

−1.00

[ −4.10; 2.10]

44.5%

16.4%

Bilgen 2013

11

20.63

5.60

11

30.00

6.03

−9.37 [ −14.23; −4.51]

18.2%

15.6%

Curro 2015

40

50.00

14.44

40

43.00

8.94

[ 1.74; 12.26]

15.5%

15.4%

Curro 2015

20

78.00

8.50

20

86.00 10.30

−8.00 [ −13.85; −2.15]

12.5%

15.1%

Agrusa 2016

13 110.00

27.50

26 120.00 35.00

−10.00 [ −30.11; 10.11]

1.1%

6.8%

Velayutham 2016

20 225.00 109.00

40 285.00 71.00

−60.00 [−112.59; −7.41]

0.2%

1.5%

Leon 2017

19

17

−20.20 [ −33.73; −6.67]

2.3%

10.1%

[ −3.48; 15.48]

4.8%

12.7%

−44.20 [ −65.44; −22.96]

1.0%

6.4%

69.90

21.50

Lu 2017

115 184.00

36.00

113 178.00 37.00

Qiu 2017

37 312.50

52.60

45 356.70 43.80

Fixed effect model

305

7.00

90.10 19.90

6.00

342

−2.87 [ −4.94; −0.80] 100.0%

Random effects model Heterogeneity: I 2 = 85%, τ2 = 70.73, p < 0.01 Test for overall effect (fixed effect): z = −2.72 (p < 0.01)

−7.44 [ −14.23; −0.66] −100

Test for overall effect (random effects): z = −2.15 (p = 0.03)

−50

0

50

−−

−− 100.0%

100

Favours 3D Favours 2D

Fig. 6 NOP

Colorectal surgery and appendectomy Statement: 3D visualization shortens operative time in right colectomy compared to 2D (LoE: moderate).

We analysed a total of 552 hits of which six papers met the inclusion criteria [122–124, 127–129], with one RCT [124]. The procedures analysed were all resectional surgery but heterogeneous. Meta-analysis of these trials highlights a significant reduction in operative time (− 13.4 min; CI95% − 26.05, − 0.83, p < 0.01) but no significant difference in complications or lymph node yield. The RCT was performed

by Curro et al. [124] and includes 40 right colectomies, 40 sigmoidectomies and 40 anterior resections, showing no difference in terms of complications or operative time.

For the topic of appendectomy, a total of 75 articles were identified; however, no article met the inclusion criteria.

compared to 2D, but not for gastric cancer or oesophageal cancer surgery. Surgical complications were reported by all six studies with no significant differences seen.

Liver, pancreas, spleen and adrenal surgery Literature search identified 666 hits for liver, 320 for pancreas, 190 for spleen and 152 for adrenal gland. Only one single prospective comparative study was found, focusing on different kinds of anatomical liver resections. The study [111] shows a significant reduction of blood loss (1255 ml versus 654 ml) and complications (33% vs. 14%) in favour of 3D. No prospective study or RCT dealing directly with the pancreas, spleen and adrenal surgery could be found.

Hence, no statement made relating to the use of 3D systems in liver, pancreas, spleen or adrenal surgery could be made.

Upper GI and bariatrics

Abdominal wall

Statements: 3D systems shorten operative time in hiatal hernia repair and mini gastric by-pass procedures (LoE: moderate).

There are no significant advantages in 3D for gastrectomy and sleeve gastrectomy (LoE: moderate).

Literature search identified 656 abstracts. After screening, six studies were included [120, 121, 130], of which three were RCTs [112–114]. The surgical procedures were hiatal hernia repair, bariatric surgery and two gastric cancer and two oesophagectomy studies. Operative time was investigated by all three RCTs with two showing a statistically significant advantage for 3D. There was significant time reduction in the 3D group for both bariatric surgery and hiatal hernia repair

No prospective study or RCT dealing directly with 3D laparoscopic abdominal wall or hernia surgery was found.

Hence, no statement could be made.

Gynaecology Statements: 3D laparoscopy could be of benefit in terms of operative time in more complex procedures (LoE: moderate).

The literature search identified 1273 hits. Five articles met the inclusion criteria [107–110, 131] containing three RCTs [107, 109, 131] and a total of 693 patients: 371 in 2D group and 322 in 3D group. All procedures required suturing in the reconstructive phase. Two studies reported

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Author's personal copy

Identification

Surgical Endoscopy

Records identified through database searching Pubmed (n = 2173)

Records identified through database searching Embase (n = 4530 )

Eligibility

Screening

Records after duplicates removed (n = 4495)

Records screened (n = 4495)

Records excluded (n = 4164)

Full-text articles assessed for eligibility (n = 331)

Full-text articles excluded, with reasons: n=35 (children<12 years) n=205 (case series /reports) n=73 (without reporting complication data)

Included

Studies included in qualitative synthesis (n = 18)

Studies included in quantitative synthesis (meta-analysis) (n = 18 )

Fig. 7 PRISMA 2009 flow diagram—22 September 2018: complications. Reproduced with permission from Moher et al. [117]

Table 5 Risk of bias (Cochrane risk tool) for RCTs selected for complications assessment Selection bias

Ruan [26] Kinoshita et al. [106] Fanfani et al. [109] Leon et al. [114] Lu et al. [112]

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Random sequence generation

Allocation concealment

Low Low Low Low Low

Low Unclear Low Low Unclear

Performance bias

Detection bias

Attrition bias

Reporting bias

Other bias

Low Low High Low Low

High High Unclear Unclear Low

Low Low Low Unclear Unclear

Low Low Low Low Unclear

Unclear Unclear Unclear Unclear Unclear

Author's personal copy Surgical Endoscopy Table 6 List of complications considered for the analysis

Author (year)

Total compli- Description cations 3D

2D

3D

2D

Aykan et al. [119]

0

4

0

Kinoshita et al. [106] Ruan [26]

4 3

6 5

4 Anastomotic leakage 3 Hematuria

Bove et al. [118]

2

6

1 Anastomotic stenosis

3 Rectal tears 1 Anemia 6 Anastomotic leakage 1 Pseudoaneurysms 4 Hematuria 1 Hematuria 2 Anemia 1 Epididymitis 2 Anastomotic stenosis 1 Vascular injury 1 Anemia 1 Dehiscence of vaginal cuff 0 1 Bladder injury 1 Hemoperitoneum 1 Urethero-vaginal fistula 3 Intraoperative bleeding

1 Urinary fistula Lara-Dominguez et al. [110]

0

2

0

Fanfani et al. [109] Currò et al. [124] Raspagliesi et al. [108]

1 1 0

1 0 3

1 Intraoperative bleeding 1 Anastomotic leakage 0

Leon et al. [114]

1

3

1 Intraoperative bleeding

3D Study

2D

Events Total Events Total

Weight Suture complications

RR

Weight

95%−CI (fixed) (random)

Aykan 2013

0

29

4

66

0.25

[0.01; 4.50]

6.6%

2.8%

Kinoshita 2015

4

57

6

59

0.69

[0.21; 2.32]

13.9%

16.0%

Ruan 2015

3

45

5

45

0.60

[0.15; 2.36]

11.8%

12.5%

Bove 2015

8

43

15

43

0.53

[0.25; 1.13]

35.4%

42.2%

Kyriazis 2015

1

5

0

10

5.73 [0.28; 118.51]

0.8%

2.6%

Dominguez 2016

2

31

7

29

0.27

[0.06; 1.18]

17.1%

10.6%

Fanfani 2016

1

42

1

48

1.14 [0.07; 17.71]

2.2%

3.1%

Currò 2016

1

25

0

25

3.00 [0.13; 70.23]

1.2%

2.4%

Raspagliesi 2017

0

15

3

60

0.56 [0.03; 10.24]

3.4%

2.8%

Leon 2017

1

19

3

17

0.30

[0.03; 2.60]

7.5%

5.0%

402

0.57

[0.35; 0.90] 100.0%

−−

0.57

[0.35; 0.92]

Fixed effect model

311

Random effects model Heterogeneity: I 2 = 0%, τ2 = 0, p = 0.81 Test for overall effect (fixed effect): z = −2.38 (p = 0.02)

0.01

Test for overall effect (random effects): z = −2.30 (p = 0.02)

0.1

1

10

−−

100.0%

100

Favours 3D Favours 2D

Fig. 8 STU

a shorter operative time in the 3D group [108, 110], but overall no statistically significant difference was observed (MD 2.12, [CI95% − 24.87 to 29.11], I2 81%, p = 0.88). No difference in terms of blood loss was seen. Meta-analysis of complications showed no differences. One study reported a

significantly shorter hospital stay in favour of 3D surgery [108].

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3D Study

2D

Events Total Events Total

Weight Suture compl (RCT+prosp)

RR

Weight

95%−CI (fixed) (random)

Kinoshita 2015

4

57

6

59

0.69 [0.21; 2.32]

24.9%

32.0%

Ruan 2015

3

45

5

45

0.60 [0.15; 2.36]

21.1%

25.0%

Dominguez 2016

2

31

7

29

0.27 [0.06; 1.18 ]

30.5%

21.2%

Fanfani 2016

1

42

1

48

1.14 [0.07; 17.71]

3.9%

6.3%

Raspagliesi 2017

0

15

3

60

0.56 [0.03; 10.24]

6.1%

5.5%

Leon 2017

1

19

3

17

0.30 [0.03; 2.60]

13.4%

10.0%

Fixed effect model

209

258

0.50 [0.25; 0.97] 100.0%

Random effects model Heterogeneity: I 2 = 0%, τ2 = 0, p = 0.90

0.51 [0.26; 1.01]

Test for overall effect (fixed effect): z = −2.04 (p = 0.04)

0.1

0.5 1 2

Test for overall effect (random effects): z = −1.92 (p = 0.05)

Favours 3D Favours 2D

−−

−− 100.0%

10

Fig. 9 XYZ

Urology Statements: 3D laparoscopy significantly reduces the operative time but not perioperative complications in prostatectomy and renal lodge surgeries (LoE: high).

The literature search identified 1653 hits. Seven studies met inclusion criteria [26, 103–106, 132, 133] with four RCTs [26, 104–106]. A total of 460 patients were included: 224 in 3D and 236 2D. The urological procedures included 122 donor nephrectomies, 121 radical prostatectomies, 93 partial nephrectomies, 54 simple nephrectomies, 40 pyeloplasties, 21 radical nephrectomies, six radical cystectomies and three other laparoscopic surgeries. The operative time was significantly shorter in two of the four RCTs [104, 105], but in meta-analysis a statistically significant was seen (MD − 25.6 min, [95 CI% − 46.45 to − 4.75], I2 88%, p = 0.02).

Blood loss was significantly lower in two of the three RCTs reporting it [26, 104]. Two of the three RCTs demonstrated shorter suturing time in 3D [26, 104]. When considering complications in suturing cases, a total of 11/179 and 18/223 for the 3D and 2D group were recorded, respectively. Metaanalysis did not show any difference in complications when including all studies or radical prostatectomy alone.

Ongoing trials At the time of writing, searching registries of privately and publicly funded clinical studies for the terms “3D” and “laparoscopy”, we found 18 ongoing RCTs [134–151] registered on ClinicalTrials.gov and ISRCTN registries: 12 in Europe, three in the United States and three in Asia. Five have completed recruiting, while three are in setup. Four deal with

13

cholecystectomy, three colorectal surgery, two gastrectomy, two hernia repair, six gynaecology surgery and one radical prostatectomy. In 10 studies the primary outcome is operative time, three error count, two complications, two patient reported outcomes (pain assessment and quality of life) and one lymph-node yield. Common secondary outcomes are conversion rate, assessment of fatigue, blood loss, readmission, mortality, oncologic safety and specimen quality, nerve sparing and functionality.

Discussion Over the past two decades, the rapid advancement in 3D imaging technology appears to have successfully overcome previous barriers to its wide clinical use. It was important for the EAES to sponsor this consensus conference in order to define recommendations, based on available evidence to provide guidance to clinicians regarding the impact of 3D laparoscopy on their practice. This project has generated consensus statements and recommendations, demonstrating that 3D laparoscopy has some advantages in reducing operating times, cognitive load and possibly complications.

This consensus follows the recent health technology objective assessment report [4] by the EAES-affiliated Italian Society of Endoscopic Surgery and new technologies (SICE). An expert consensus was now felt appropriate as a combination of structured review of the evidence with leading multi-disciplinary technological and surgical expertise to generate statements and recommendations for clinical practice. We used a modified Delphi approach to reach consensus on the statements and grade of evidence adhering to

Author's personal copy Surgical Endoscopy

the PRISMA, Cochrane risk of bias and GRADE principles.

Agreement was reached on 13 proposed consensus statements (Table 7). Paucity of available evidence limited us to two recommendations underpinned by the meta-analyses.

This project also involved pooling the evidence from multiple studies to allow meaningful conclusions by increasing the sample size. Meta-analysis of the included clinical studies across all specialities showed 3D systems reduced operative time by a mean of 11 min representing 8% of case time. This effect size was larger in procedures involving laparoscopic suturing. Box trainer task time was also shorter with 3D. We found a large body of evidence investigating the role of 3D on the performance on box training. Results of the laboratory experimental trials showed 3D was associated with significantly better performance than 2D in the majority of technical tasks. Consideration for the learning effect when repeating identical tasks with a different imaging modality should be made as performance could be higher irrespective of imaging used. While affected by the risk of bias and methodological flaws, our findings suggest that 3D technology improves laparoscopic box trainer simulator task performance. This could speed time to competency with fewer enacted error events in laparoscopically naïve or junior participants. There are no data, however, on whether these benefits translate to operating room performance or patient outcomes. A Cochrane review concluded that the benefits of box training have not been shown to translate to real-world performance [152].

As improved operating performance represents the goal of all minimal access training, further dedicated translational and longitudinal studies are clearly indicated.

The major output of this consensus is represented by a clear advantage of 3D in the overall rate of complications, in particular after surgical procedures involving suturing.

The data should be considered cautiously due to the variety of procedures; however, this is likely to increase the generalizability of the results. Nevertheless, this difference was even more evident when only complications strictly related to vision, such as intraoperative injuries, leaks and fistulas, were considered. When including only RCTs and prospective studies, the benefit of the use of 3D increased showing a halving of complications, while maintaining no heterogeneity. This could be explained by the increasing task complexity with laparoscopic suturing. It appears that presence of stereoscopy seems to be crucial due to a more accurate appreciation of depth perception during this technique. This is consistent with the other studies which demonstrated superiority with 3D suturing technique [153].

Nevertheless, this benefit of 3D was observed as either a secondary endpoint in the vast majority of the studies or in small cohorts. Further robust research is required to

confirm these findings and specifically investigate the true benefit of this technique on clinical outcomes.

Limitations Our findings are in line with the available 2D/3D systematic reviews on this topic [75, 154, 155] which reported similar methodological concerns. In identified studies including a number of RCTs, significant heterogeneity was observed which limited the number of recommendations made. There is a clear need for further randomized studies that use validated and reproducible tasks or standardization of intervention delivery. Wherever possible equipment, viewing distance, table height and ergonomics should also be standardized. Compliance with the CONSORT statement, A-priori sample size calculations, homogenous participant groups, surgical experience, stereopsis visual assessment, validated blinded assessment methods and robust randomisation tools are additional considerations that would strengthen results and add to our understanding. Although we have identified that 3D imaging can assist surgical efficiency, no study attempted to assess quality of surgery or cost-effectiveness of this technology. Limited by study reporting, we could not investigate the effective of varying stereopsis abilities on outcome data.

It is well acknowledged that there is approximately 1–30% percent of the general population, and 9.7% of surgeons are stereo blind and would not be expected to benefit from 3D [156, 157]. This may limit the generalizability of our proposed recommendations and testing for stereo blindness is strongly advocated before clinical practice or research involving 3D systems.

Future research This exercise has highlighted areas of equipoise as well as clinically important gaps in the literature and can serve as a guide for future clinical studies. Currently, there are 18 ongoing clinical trials that are related to this topic and already registered. Health economic analysis is required to evaluate the cost-effectiveness of 3D systems and the observed reduction in operative time and complication data. Dedicated research assessing the impact of 3D systems on clinical outcomes is indicated.

13

13 Recommendations

3D vision improves outcomes for junior trainees performing standardized box trainers tasks using properly setup 3D HD systems and passive polarized glasses (LoE: high) Training The use of 3D imaging systems improves laparoscopic box trainer task completion time and error rate but this benefit has not been studied in clinical practice (LoE: moderate) Cognitive load 3D laparoscopy does not introduce a higher cognitive workload and may result in decreased experienced cognitive workload provided that the viewing setup is optimal (LoE: moderate) Pitfalls 3D systems may increase visual fatigue, discomfort and headaches when setup is not optimal (LoE: moderate) Costs and cost/effectiveness No statement Meta-analysis of the of potential clinical benefits of the use of 3D vision Operative time 3D laparoscopy shortens the operative time across all analysed surgical We recommend the use of 3D vision in laparoscopy to reduce the operaspecialities (general surgery, urology and gynaecology) (LoE: high) tive time (GoR: low) Future research is recommended to specifically investigate the poten Complications The pooling of data from the different settings seems to suggest a tial benefit of the use of 3D laparoscopy system on complication rate lowering in the overall rate of complications after surgical procedures (GoR: high) involving suturing in 3D laparoscopy (LoE: low) Cholecystectomy There is no evidence that 3D vision is superior or inferior to 2D in laparoscopic cholecystectomy in terms of intra- and post-operative complications (LoE: moderate) Less experienced surgeons could benefit from 3D imaging resulting in shorter operative time in laparoscopic cholecystectomy (LoE: low) Colorectal surgery and appendectomy 3D visualization shortens operative time in right colectomy compared to 2D (LoE: moderate) Upper GI and bariatrics 3D systems shorten operative time in hiatal hernia repair and mini gastric by-pass procedures (LoE: moderate) There are no significant advantages in 3D for gastrectomy and Sleeve Gastrectomy (LoE: moderate) Liver, pancreas, spleen and adrenal surgery No statement Abdominal wall No statement Gynaecology 3D laparoscopy could be of benefit in terms of operative time in more complex procedures (LoE: moderate) Urology 3D laparoscopy significantly reduces the operative time but not influence perioperative complications in prostatectomy and renal lodge surgeries (LoE: high)

General Topics Impact on basic laparoscopy

Statements

Table 7 List of statements and recommendations

Author's personal copy Surgical Endoscopy

Author's personal copy Surgical Endoscopy

Conclusion 3D laparoscopic systems reduce procedure time in both the operating room and box trainer settings. 3D vision may also reduce perioperative complications particularly in procedures involving laparoscopic suturing.

Acknowledgements We would like to acknowledge Nicoletta Colombi for helping us in determining the correct syntax for the search strategy.

Funding This project was supported and funded by the EAES.

Compliance with ethical standards Disclosures Nader Francis and Nathan J Curtis received technical support consisting of 3D stacks from Karl Storz Endoscopy UK Ltd as a free research loan for their study “The role of 3D laparoscopic rectal surgery: a randomised controlled trial” (ISRCTN59485808). Alberto Arezzo, Nereo Vettoretto, Marco Augusto Bonino, Daniele Amparore, Simone Arolfo, Manuel Barberio, Luigi Boni, Ronit Brodie, Nicole Bouvy, Elisa Cassinotti, Thomas Carus, Enrico Checcucci, Petra Custers, Michele Diana, Marilou Jansen, Joris Jaspers, Gadi Marom, Kota Momose, Beat P Müller-Stich, Kyokazu Nakajima, Felix Nickel, Silvana Perretta, Francesco Porpiglia, Francisco Sánchez-Margallo, Juan A Sánchez-Margallo, Marlies Schijven, Gianfranco Silecchia, Roberto Passera and Yoav Mintz have no conflict of interest or financial ties to disclose.

Research involving human and animal participants This article does not contain any original study with human or animal subjects.

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28.

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Affiliations Alberto Arezzo1 · Nereo Vettoretto2 · Nader K. Francis3 · Marco Augusto Bonino1 · Nathan J. Curtis3,4 · Daniele Amparore5 · Simone Arolfo1 · Manuel Barberio6 · Luigi Boni7 · Ronit Brodie8 · Nicole Bouvy9 · Elisa Cassinotti7 · Thomas Carus10 · Enrico Checcucci5 · Petra Custers9 · Michele Diana6 · Marilou Jansen11 · Joris Jaspers12 · Gadi Marom8 · Kota Momose13 · Beat P. Müller-Stich14 · Kyokazu Nakajima13 · Felix Nickel14 · Silvana Perretta6 · Francesco Porpiglia5 · Francisco Sánchez-Margallo15 · Juan A. Sánchez-Margallo15 · Marlies Schijven11 · Gianfranco Silecchia16 · Roberto Passera1 · Yoav Mintz8 1

Department of Surgical Sciences, University of Torino, Corso Dogliotti 14, 10126 Torino, Italy

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4

5

6

7

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Montichiari Surgery, ASST Spedali Civili Brescia, Montichiari, Italy

Department of Surgery, Center for Minimally Invasive Surgery, Asklepios Westklinikum Hamburg, Hamburg, Germany

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Department of General Surgery, Yeovil District Hospital NHS Foundation Trust, Higher Kingston, Yeovil, UK

Department of Surgery, Academic Medical Centre Amsterdam, Amsterdam, The Netherlands

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Department of Surgery and Cancer, St Mary’s Hospital, Imperial College London, London, UK

Department of Medical Technology and Clinical Physics, University Medical Centre Utrecht, Utrecht, The Netherlands

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Division of Urology, ESUT Research Group, San Luigi Gonzaga Hospital, Orbassano, Torino, Italy

Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Suita, Osaka, Japan

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IRCAD, Research Institute Against Digestive Cancer, Strasbourg, France

General-, Visceral-and Transplant Surgery, University of Heidelberg Hospital, Heidelberg, Germany

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Department of Surgery, Fondazione IRCCS Cà Granda, Policlinico Hospital, University of Milan, Milan, Italy

Jesús Usón Minimally Invasive Surgery Centre, Cáceres, Spain

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Department of Medico-Surgical Sciences and Biotechnologies, Faculty of Pharmacy and Medicine, Sapienza University of Rome, Rome, Italy

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Department of Surgery, Hadassah-Hebrew University Medical Center, Jerusalem, Israel

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Department of Surgery, Maastricht University Medical Center, Maastricht, The Netherlands

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Surgical Endoscopy (2018) 32:2986–2993 https://doi.org/10.1007/s00464-017-6006-y

and Other Interventional Techniques

NEW TECHNOLOGY

Why laparoscopists may opt for three-dimensional view: a summary of the full HTA report on 3D versus 2D laparoscopy by S.I.C.E. (Società Italiana di Chirurgia Endoscopica e Nuove Tecnologie) Nereo Vettoretto1 · Emanuela Foglia2 · Lucrezia Ferrario2 · Alberto Arezzo3 · Roberto Cirocchi4 · Gianfranco Cocorullo5 · Giuseppe Currò6 · Domenico Marchi7 · Giuseppe Portale8 · Chiara Gerardi9 · Umberto Nocco10 · Michele Tringali11 · Gabriele Anania12 · Micaela Piccoli7 · Gianfranco Silecchia13 · Mario Morino3 · Andrea Valeri14 · Emauele Lettieri15,16 Received: 8 March 2017 / Accepted: 6 December 2017 / Published online: 24 January 2018 © The Author(s) 2018. This article is an open access publication

Abstract Background Three-dimensional view in laparoscopic general, gynaecologic and urologic surgery is an efficient, safe and sustainable innovation. The present paper is an extract taken from a full health technology assessment report on threedimensional vision technology compared with standard two-dimensional laparoscopic systems.

Methods A health technology assessment approach was implemented in order to investigate all the economic, social, ethical and organisational implications related to the adoption of the innovative three-dimensional view. With the support of a multi-disciplinary team, composed of eight experts working in Italian hospitals and Universities, qualitative and quantitative data were collected, by means of literature evidence, validated questionnaire and self-reported interviews, applying a final MCDA quantitative approach, and considering the dimensions resulting from the EUnetHTA Core Model.

Results From systematic search of literature, we retrieved the following studies: 9 on general surgery, 35 on gynaecology and urology, both concerning clinical setting. Considering simulated setting we included: 8 studies regarding pitfalls and drawbacks, 44 on teaching, 12 on surgeons’ confidence and comfort and 34 on surgeons’ performances. Three-dimensional laparoscopy was shown to have advantages for both the patients and the surgeons, and is confirmed to be a safe, efficacious and sustainable vision technology.

Conclusions The objective of the present paper, under the patronage of Italian Society of Endoscopic Surgery, was achieved in that there has now been produced a scientific report, based on a HTA approach, that may be placed in the hands of surgeons and used to support the decision-making process of the health providers.

Keywords Three-dimensional vision · Laparoscopy · Surgery · Health technology assessment · Systematic review The introduction of new technologies into the healthcare systems should be guided frequently by qualitative approaches, since the relation between manufactures/suppliers and physicians is not economically sustainable [1] without an empirical and scientific investigation of all the possible benefits and disadvantages related to implementation of the Electronic supplementary material The online version of this article (https://doi.org/10.1007/s00464-017-6006-y) contains supplementary material, which is available to authorized users. * Nereo Vettoretto nereovet@gmail.com Extended author information available on the last page of the article

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innovation. As recommended by evidence-based medicine issues, efficacy and safety information are mandatory for the introduction of a new technology [2]. In recent years, other dimensions have acquired great importance, since a technology assessment could not consist only of cost-effectiveness aspects [3]. This is the reason for the growing attention on health technology assessment (HTA), an instrument useful in guiding the introduction of all healthcare technologies, related to the evaluation of economic, ethical, social, legal and organisational dimensions consistent with clinical governance tools. Health technology assessment (HTA) is a part of decision-making process in health system and could be considered as a form of policy research and as a source of

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good evidence and at the meantime that is embedded in further public and professional policy process.

HTA may also be considered as a support in the dialogue between clinicians and healthcare providers [4] and has been verified in the surgical context, where innovation plays a key role; in particular, minimally invasive surgery where, although it requires technological advancement and costly devices to be performed [5], it has proven to be effective in many fields of general, urologic and gynaecologic surgery.

One such new technology in laparoscopy uses a new vision method, three-dimensional viewing (3D) that responds to the exigency of improving two-dimensional systems (2D), advancing towards a more realistic standard and closer to “open surgery” vision. However, while 3D systems are now emerging in the surgical market, as an improvement on 2D systems, they are still not widely disseminated, even though they are used in other non-medical fields.

Moving on from these premises, SICE (Società Italiana di Chirurgia Endoscopica e nuove tecnologie—Italian Society of Endoscopic Surgery and new technologies, which is affiliated to the European Society of Endoscopic Surgery—EAES), has focused its attention on 3D laparoscopic technologies within the Italian surgical setting, by means of a specific survey devoted to SICE affiliates. Sixtytwo practices (university and community hospitals, with a private and public ownership) reported that 3D laparoscopy could be a favourable surgical strategy both for surgeons and for patients (65% of responders) and 82% of the surgeons involved in the survey reported that 3D could be considered the “future” of laparoscopy.

As a result, the SICE directory created a multi-disciplinary team (composed of surgeons selected by SICE, operating theatre nurses selected by Italian Association of Operating Theater Nurses—AICO, healthcare sector researchers from LIUC Cattaneo University, managerial engineers from Milan Politecnico, HTA experts from Lombardy Region, methodology experts and statisticians from Mario Negri Institute for Research), with the aim of producing a scientific report based on a HTA approach.

The objective of the present paper is the evaluation of the 3D technology compared with that of the 2D technology in the settings of general, urologic and gynaecologic surgery, and in various procedures, using a full HTA evaluation.

Methods To achieve the above-mentioned objective, a health technology assessment was implemented. The evaluation was based on the generally accepted “Core Model” developed by the EUnetHTA Consortium [6], deploying 9 dimensions (version 2.1, April 2015) and considering the related

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criteria of evaluation derived from the Lombardy Region technologies assessment institutional approach [7].

The following dimensions were examined: general relevance of the pathologies (description of the diseases in which the technology could influence the outcome) and technologies (comparison of the characteristics of the existing 2D and 3D systems), safety issues (morbidity, intraoperative blood loss, safety and drawbacks of surgeons), efficacy, economic impact (activity-based cost analysis and budget impact analysis), equity, ethical and social impact, legal issues, and organisational impact (hospital stay, comfort for the surgeons, operating time and learning curve). This process was conducted considering the following setting: general surgery, gynaecology, urology, ongoing studies, teaching, pitfalls and drawbacks, surgical skills and comfort of the surgeon.

Ad hoc questionnaires were created and administered to a pool of Italian “surgical opinion” leaders (N = 8) in order to investigate their perceptions concerning equity, ethical, social, organisational and legal implications comparing 2D and 3D systems. The questionnaires were structured in accordance with a 7-item Likert scale ranging from − 3 (worse impact) to + 3 (better impact).

To obtain safety, efficacy and organisational dimensions, a systematic review of the literature evidence was carried out for each clinical or simulated, respectively, using PICO [9], PRISMA [10] and Cochrane methodologies [11]. PubMed, Scopus and Cochrane databases were systematically searched up to July 2016 for published randomised clinical trials, observational studies and metaanalyses of the selected setting and interventions.

We used the following terms and also their MESH term(s), if available: 3D, three-dimensional, 2D, twodimensional, surgery, laparoscopy. We combined this search with each relevant setting (clinical or simulated) and their specific terms for the following categories: general surgery, gynaecology and urology, surgeons’ confidence and comfort, pitfalls and drawbacks, surgeons’ performances and teaching.

We also systematically searched the following registries up to May 2016: http://www.clinicaltrials.gov, http://www. clinicaltrialsregister.eu, http://www.anzctr.org.au, to detect ongoing studies aimed to compare 3D vs. 2D approaches.

All studies were classified using the table ‘Levels of Evidence Oxford Centre for Evidence-Based Medicine 2011’ to assess the role of each publication in terms of evidence generated.

After the medical database and registry searches, two reviewers, one surgeon and one methodologist, independently screened abstracts and full texts, and separately proceeded with data extraction. Discrepancies were solved by consensus.

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Results Comparison of the technologies under assessment A comparative analysis of technologies between 2D and 3D systems used in the Italian market was undertaken using the technical characteristics provided by manufacturers/suppliers. Four different providers of the new 3D technology were contacted and, upon request, made available data on the standard 2D and the new 3D equipment. No significant differences were found between the various 2D systems.

All the 3D technologies utilised full-HD 3D (≥ 1920 × 1080 pixels) with a 26″–32″ monitor. All systems were provided with “light and comfortable” passively polarized glasses and did not require synchronisation with the video images (as with earlier 3D systems [33]). The main characteristics of 2D and 3D systems (visual resolution, images distribution and optics) were comparable and superimposable. The systems consisted of a camera, monitor, light source and image processor: no collateral accessories were considered in the comparative cost and performance analysis. Data on median costs of the laparoscopic columns (based on the industries’ sales catalogues) were 64,774.36 euro for the 2D column and 107,577.54 euro for the 3D column. Data on dissemination of the 3D systems in Italy showed a penetration in Italian surgical units of around 15% (from a total of 876 surgical units, data extracted from an Italian national database [34]). Also considered was that the potential penetration of the new technology could reach approximately 100%, since all surgical units in Italy have a 2D laparoscopic column in their operating theatres.

Efficacy, safety and organisational results: evidence from the literature review Seven systematic reviews were accomplished, each supported by 8–44 papers (comprehending systematic reviews, randomised controlled studies, comparative studies or prospective–retrospective cohort studies) after a selection by titles and abstract, removal of duplicates and exclusion of non-pertinent studies after full-text retrieval, as shown by Prisma flow diagrams in Online Appendix 1. Summary of findings and results for each selected study have been drafted and the data were summarised for each EuNetHTA dimension.

General relevance of the pathology The relevance of the health problem was determined by comparing articles related to different operations for 3D vs.

2D laparoscopy in the three settings of general, urologic

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and gynaecologic surgery. The analysed operations were cholecystectomy, colectomy, adrenalectomy, hepatic resection, pulmonary resection, obesity surgery in the context of general surgery; hysterectomy and pelvic lymphectomy for gynaecological surgery; radical transperitoneal and retroperitoneal prostatectomy, pyeloplasty, urethroplasty and radical cystectomy for urologic surgery. A hypothetical representative pool of patients, who had undergone these surgical procedures, was defined as a general case mix of a standard and generic Italian hospital. The hypothesised case mix was derived from a recent survey performed in Campania Region [18]. In this specific setting, in the year 2014, 8566 patients underwent some kind of general, gynaecologic or urologic surgery. Out of these, 3544 patients (41.38%) underwent one of the laparoscopic operations described (Table 1).

Evaluation of outcomes Two clinical settings and 4 simulated settings were explored: • 3D vs. 2D in the clinical setting of general surgery: 9 • • • • •

comparative studies (4 randomised controlled studies— RCTs) out of 235 screened papers; 3D vs. 2D in the clinical setting of gynaecology and urology: 35 comparative studies (1 systematic review—SR and 12 RCTs) out of 667 screened papers; 3D vs. 2D, pitfalls and drawbacks in simulated settings: 8 comparative studies (5 RCTs) out of 56 screened papers; 3D vs. 2D, value in teaching for simulated settings: 44 comparative studies (1 SR and 36 RCTs) out of 267 screened papers; 3D vs. 2D, surgeons’ confidence and comfort: 12 comparative studies out of 187 screened papers; 3D vs. 2D, surgeons’ performances in the simulated setting: 34 studies (1 SR and 26 RCTs) out of 149 screened papers.

Significativity was investigated with Excel’s descriptive Statistics tool (Microsoft®).

Results in clinical settings concerning morbidity reported a significant difference in urinary continence favouring 3D in radical prostatectomy and cystectomy (p < 0.02 and 0.05), and a substantial overlap in safety issues for other surgeries.

Table 1 Case mix in laparoscopic surgery in a recent audit from a high-volume hospital in Regione Campania Surgical field

No. of patients (%)

General surgery Gynaecology Urology Total

2567 (72.4%) 163 (4.6%) 814 (23.0%) 3544 (100%)

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Table 2 Operating times in general surgery

Hospitalisation

Authors

2D

3D

Difference (min) Difference (%)

Velayutham et al. [42] Sahu et al. [43] Currò et al. [12] Bilgen et al. [39] Yang et al. [44] Currò et al. [12] Median value

284 54 60 30 107 100

225 40 48 20 86 88

− 59 − 14 − 12 − 10 − 21 − 12

− 20.77 − 25.93 − 20.00 − 33.33 − 19.63 − 12.00 − 21.94

No significant differences were found between 2D and 3D technologies considering the hospital stay.

Surgeons’ comfort Significant differences were observed in depth perception [16, 19–22] and eye–hand coordination [23, 24], favouring the 3D approach.

Surgeons’ performance

Table 3 Operating times in Urology Fonte

2D

3D

Difference (min) Difference (%)

Aykan et al. [45] Xu et al. [46] Bove et al. [40] Tang et al. [41] Median value

190 124 241 150.6

131 106 162 133.1

− 59 − 18 − 79 − 17.5

− 31.05 − 14.52 − 32.78 − 11.62 − 22.49

Haemorrhages were significantly lower for 3D pelvic lymphectomy (38 vs. 65 ml, p = 0.033) and radical prostatectomy (p < 0.05), though similar in other surgical contexts.

The surgeons’ safety and comfort in the clinical setting had been examined only by three Italian studies [12–15] and demonstrated a significant advantage in terms of less visual fatigue and neck pain in 3D laparoscopy. Simulated settings failed to show statistically significant differences in the surgeons’ perspective between the two visual systems, even if results seemed inverse favouring the 2D setting but with a discomfort (in particular, related to dizziness and physical discomfort, worse in the 3D setting in 2 out of 19 studies [16, 17]) that was described as “tolerable”.

The efficacy value used in the analysis was the operating time, related to the two comparators. No significant differences emerged in the clinical setting of general surgery, even if 3D seemed to shorten the median time. This was particularly evident in laparoscopic cholecystectomy and when isolating the subgroup of “non-expert” or novice surgeons, in which the operating time significantly shortened.

To evaluate the organisational impact for general surgery, the differences in operating time were recalculated in terms of median values, considering only the articles with a significant difference between 2D and 3D (Tables 2 and 3).

Tables 2 and 3 show a significant advantage in implementing the 3D technologies, both in general surgery and urology.

However, no significant differences were found within the ob-gyn setting. These results, deriving from the literature evidence, were the differential values (if reported) used in the budget impact analysis in order to estimate the overall economic savings assuming the hospital point of view.

The experimental setting reported better performances (speed, accuracy) with 3D vision, both in the expert and in the novice surgeons [19, 21, 25–29]. The reduction in time was related to various tasks at the simulator (peg transfer, shape, and paper cutting, suturing, rope passing, needle capping), all statistically significant, and some studies evidenced a reduction of the error rate [31]. This is particularly significant for the novice surgeons [20, 32] who are able to perform difficult tasks more easily and feel more comfortable, and reflects on learning curves with a significant advantage in the performance of the surgical practices overall. Collateral effects (nausea, eye fatigue, visual disturbances) did not show any statistical difference between the two technologies.

Economic dimension Since no evidence was found concerning the economic impact of 3D technology (from 42 records screened, 27 articles assessed, 27 articles excluded), this dimension was investigated through the implementation of an activity-based cost analysis (ABC) [35–37], considering a 12-month time horizon and assuming the hospital point of view. In particular, the economic evaluation of each patient undergoing a surgical procedure considered both the “surgical pathway” and the “medical pathway” in terms of length of stay, laboratory tests and other diagnostic procedures. Data included direct costs of personnel working in the operating theatre (surgeons, nurses, anaesthetists, auxiliary personnel and technical staff).

The median cost of the surgical pathway (divided in operating room costs and personnel costs) and of medical pathway is summarised in Table 4. It had been established that the median life of a laparoscopic column is approximately 8 years that provided a cost per year of 8.096,80 euro for the 2D system, and 13.447,19 euro for the 3D system.

A patient’s related cost for the two technologies is shown in Table 5. The ABC, in the analysed/optimised context, reported savings ranging from 1.173 to 1.341% per year, in urology and general surgery, while an increase of 0.232% of cost per year was realised in gynaecology.

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Table 4 Surgical and medical pathway hospital cost

Surgical field

Surgical pathway (devices)

Surgical pathway (human resources)

Medical pathway

Total

General surgery Gynaecology Urology

€3294.57 €1505.63 €3229.72

€357.64 €283.79 €320.72

€2148.00 €2685.00 €2416.50

€5800.21 €4474.42 €5966.94

Table 5 Comparative costs per patient per year Surgical field

No. of patients

2D system

3D system

General surgery Gynaecology Urology

2567 163 814

€1.00 €15.78 €3.16

€1.67 €26.21 €5.25

From a budget impact point of view, the introduction of a new health technology in a specific setting needs a budget impact analysis (BIA) to support the policy makers’ decisions, in different contexts, from health system regulation to the hospital sustainability, both settings with limited economic resources [38]. In this case, laparoscopic operations were compared, presuming that they would all be performed using either 2D or 3D technology, in the same context (highvolume hospital with all medical specialties) as analysed previously. Over 1 year of activity of the three surgical branches, the adoption of a 3D system of vision would lead to an economic saving of 255,035.05 euro (− 12,451%), based on a reduction in the operating time.

To ensure the robustness of the results, a sensitivity analysis was performed, by changing the data on the reduction of the operating time using 3D technology, based on the level of evidence and recommendation of the literature data.

In particular, data extracted from articles regarding general surgery, general and gynaecologic surgeries were classified with a strength between 1 and 2 (randomised controlled studies and meta-analysis [12, 13, 39, 40]), and general and gynaecologic surgery classified between 3 and 4 (comparative non-randomised or case series [42–46]). Results of the budget impact sensitivity analysis confirmed the convenience of the 3D systems, with economic advantages ranging from 1.14 to 1.37%.

Organisational, equity, ethical, social and legal impacts: evidence from the professionals’ perceptions These dimensions were investigated with the support of qualitative questionnaires administered to experts in the field of surgery. The results are summarised in Table 6.

With regard to the qualitative assessment of the organisational dimension, it emerged that, over a time horizon of 12 months, the introduction of the innovative technology

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Table 6 Professionals’ perception regarding organisational, equity, ethical, social and legal aspects Item Organisational aspects

Additional staff required Staff training Support staff training Investment in additional areas Investment in additional equipment Impact on the purchasing processes Organisational changes Product manageability Improvement in the learning curve Average value Equity aspects Acceptability of the technology Knowledge of the technology Hospital waiting list Accessibility Health migration phenomena Average value Ethical and social aspects Patients’ autonomy preservation Impact on social costs Impact on post-operative pain Impact on the patients’ satisfaction Impact on the development of surgical complications Average value

3D system 0.857 − 0.571 − 0.429 0.571 0 0.286 0.429 1.714 1.714 0.508 1.875 0 − 0.5 0.375 1 0.55 0.5 0.88 0.5 0.88 1.63 0.875

required the institutionalisation of specific training courses devoted to the healthcare professionals and support staff directly involved in the procedure. These had a positive impact on both the internal and the purchasing processes.

Furthermore, the innovative technology could be considered as the preferable surgical strategy, in particular for its ability to accelerate the learning curve of the operators involved and its manageability, thus positively affecting the operating theatre time.

From an equity point of view, the adoption of the innovative technology would generate health migration phenomena and would lead to a significant decrease in waiting lists,

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thus improving access to care in order to meet the citizens’ health needs.

With regard to the ethical and social impact, clinicians declared that patients were able to experience a positive impact from the use of the innovative technology due to a decrease in the post-surgical pain procedure and to a lower risk in developing future complications.

The analysis of the legal implications reported that the two technologies under assessment could be considered superimposable in their measurement, both considering the indication of use for all the surgical procedures and for all the categories of patients, and the presence of authorisations for use.

Discussion and conclusions The development of laparoscopic surgery, over the past 20 years, has improved the outcomes of patients by reducing surgical trauma, hospital stay, post-operative pain and performance status. However, laparoscopy is more difficult to perform and to apprehend, mainly due to two-dimensional vision, limited movements and instrumentation, and impaired tactile feedback.

To bypass some of these problems, research has turned to three-dimensional vision, applied per se or associated to robotic platforms. To date, there have been few clinical trials as 3D platforms are poorly disseminated in surgical practices, mainly due to cost-containment reasons. Clinical guidelines and consensus conferences are not sufficient in order to validate the introduction of a new surgical technology: the sustainability and the economic impact, associated with the evidence of a clinical improvement (related both to the patients and the operators) requires an in depth examination.

A strategic tool that could overcome the above-mentioned limitations is the health technology assessment (HTA). However, it would require a new common language to be shared between physicians, engineers, managers and healthcare providers.

The present paper may be considered as the first attempt to produce a complete HTA report within the surgical field, as a multi-disciplinary exercise involving all the professionals, under the patronage of the Italian Society of Endoscopic Surgery and new technologies (SICE), an affiliate of the European Association of Endoscopic Surgery (EAES).

Results of the clinical trials favour 3D vision in terms of blood loss, operative time and hospital stay (though the main results, regarding comfort for the surgeon, have been investigated in simulated settings that have shown a better depth perception, hands–eyes coordination and accuracy). The performances, in particular for novice surgeons, appear to be improved using 3D vision, with faster

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and more precise resolution of laparoscopic tasks. Sensations of neck and back pain, physical fatigue, nausea and dizziness have different rates between the clinical setting (in which they appear to be worse for 3D vision) and the simulated setting (in which they ameliorate for 3D vision), even if the worse results seem to be associated with earlier 3D systems and lose significance in the later ones.

All this suggested that there was a need for further studies and investigation in order to better point out such drawbacks.

In this view, literature reported 14 ongoing clinical trials related to this topic (http://www.clinicaltrials.gov, https://www.clinicaltrialsregister.eu, http://www.anzctr. org.au), 12 of which are RCTs, starting between January 2010 to March 2015 and that are distributed throughout Europe (5), America (2) and Asia (7). Of these, five have been completed but their results have not yet published, seven are still recruiting and two are not yet recruiting.

Their research is focused on laparoscopic cholecystectomy (4), hernia repair (2), colectomy (1), pancreatectomy (1), gastric surgery (1), transanal endoscopic microsurgery (1), gynaecologic–urologic pelvic surgery (2) and laparoscopy in general (2). Results are expected by 2020.

The multi-dimensional evaluation suggested, as perceived by Italian surgeons in the ex-ante survey, some advantages of the implementation of the new technology, without the need of significant economic additional investment for the Healthcare Systems. The economic assessment, in fact, reports how the implementation of the new technology, in particular if considered whenever a renewal of the laparoscopic instrumentation is programmed, would not require additional investment, thus resulting in a substantial economic neutrality and sustainability. Furthermore, 3D vision could be considered not only a privilege for centres of excellence, but instead the norm, applicable in most different realities of public or private healthcare contexts.

Finally, it should be mentioned that the present study has limitations; for example, the surveys and the consensus were related specifically to surgical experts, without participation of other subjects who nowadays also take part in health decisions, such as patients’ associations [8, 30].

Acknowledgements Politecnico di Milano, IRCCS-Istituto di Ricerche Farmacologiche Mario Negri, Regione Lombardia, LIUC-Università Cattaneo, Associazione Italiana Ingegneri Clinici, Associazione Infermieri di Camera Operatoria, Federazione Italiana Aziende Sanitarie e Ospedaliere, Bbraun Italia, Conmed Italia, Olympus Italia, Storz Italia. Thanks also to the rest of the scientific committee: Ferdinando Agresta, Valentino Fiscon, Carlo Bergamini, Gaspare Gullotta, Marco Ettore Allaix, Gianandrea Baldazzi, Fabio Cesare Campanile, Giovanni Sgroi, Sarah Molfino, Gian Paolo Zanchi, Tommaso Fontana, Pietro Barbieri, Angelo Iossa, Giuseppe Navarra, Enrico Restini, Luigi Boni, Ugo Elmore, Gianluca Garulli, Mario Guerrieri, Wanda Luisa Petz, Alessandro Puzziello, Simone Vita.

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Compliance with ethical standards Disclosures Dr. Foglia reports grants from Gilead Sciences Srl, grants from Fondazione Cariplo, non-financial support from ACOI/SIC/SICE/ SICU Surgery Societies, personal fees from Formazione Peperosso Srl, outside the submitted work. Dr. Morino reports personal fees from Karl Storz Endoscopie, outside the submitted work. Dr. Tringali reports personal fees and non-financial support from ALTEMS—Catholic University Roma, personal fees and non-financial support from Innovative Medicines Joint Undertaking 2 (IMI2 JU), Bruxelles, personal fees and non-financial support from Ist. Sup. Studi Sanitari G. Cannarella, Roma, personal fees from Universita’ Piemonte Orientale, Novara, personal fees from AGENAS (Italian Agency Health Care Quality and Research), Roma, personal fees from MA Provider SrL, Milano, nonfinancial support from SIFO (Italian Society Hospital Pharmacysts), non-financial support from SHIRE, Milano, non-financial support from Italian Ministry of Health, Roma, non-financial support from ACOI/ SIC/SICE/SICU Surgery Societies, outside the submitted work. Dr. Vettoretto reports personal fees from BBraun, outside the submitted work. Drs Anania, Arezzo, Cirocchi, Cocorullo, Currò, Ferrario, Gerardi, Lettieri, Marchi, Nocco, Piccoli, Portale, Silecchia, Valeri have no conflicts of interest or financial ties to disclose.

Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

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Affiliations Nereo Vettoretto1 · Emanuela Foglia2 · Lucrezia Ferrario2 · Alberto Arezzo3 · Roberto Cirocchi4 · Gianfranco Cocorullo5 · Giuseppe Currò6 · Domenico Marchi7 · Giuseppe Portale8 · Chiara Gerardi9 · Umberto Nocco10 · Michele Tringali11 · Gabriele Anania12 · Micaela Piccoli7 · Gianfranco Silecchia13 · Mario Morino3 · Andrea Valeri14 · Emauele Lettieri15,16 1

Montichiari Surgery, ASST degli Spedali Civili di Brescia, V.le Ciotti 154, 25018 Montichiari (BS), Italy

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IRCCS - Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy

2

Centre for Health Economics, Social and Health Care Management, LIUC-Università Carlo Cattaneo, Castellanza (VA), Italy

10

Clinical Engineering, ASST Settelaghi, Varese, Italy

11

Direzione Generale Welfare - Regione Lombardia, Mantova, Italy

3

Center for Minimal Invasive Surgery, University of Turin School of Medicine, Turin, Italy

12

4

General and Oncologic Surgery, University of Perugia, Perugia, Italy

General and Thoracic Surgery, University of Ferrara, Ferrara, Italy

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5

General and Emergency Surgery, Azienda Ospedaliera Universitaria Policlinico P. Giaccone, Palermo, Italy

General Surgery, Sapienza University of Rome Polo Pontino, Latina (RM), Italy

14

6

General and Oncologic Surgery, University of Messina, Messina, Italy

General, Emergency and Minimally Invasive Surgery, Azienda Ospedaliera Universitaria Careggi Firenze, Firenze, Italy

15

7

General Surgery, Ospedale Civile di Baggiovara, Modena, Italy

Deparment of Management, Economics and Industrial Engineering, Milan Politecnico, Milan, Italy

16

8

General Surgery, Ospedale di Cittadella, Padova, Italy

Centre for Healthcare Improvement, Chalmers University of Technology, Gothenburg, Sweden

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