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2D versus 3D laparoscopic total mesorectal excision: a developmental multicentre randomised controlled trial

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Title: 2D versus 3D laparoscopic total mesorectal excision: a developmental multicentre randomised controlled trial
Authors: Curtis, NJ
Conti, JA
Dalton, R
Rockall, TA
Allison, AS
Ockrim, JB
Jourdan, IC
Torkington, J
Phillips, S
Allison, J
Hanna, GB
Francis, NK
Item Type: Journal Article
Abstract: Aims The role of laparoscopy in rectal cancer has been questioned. 3D laparoscopic systems are suggested to aid optimal surgical performance but have not been evaluated in advanced procedures. We hypothesised that stereoscopic imaging could improve the performance of laparoscopic total mesorectal excision (TME). Methods A multicentre developmental randomised controlled trial comparing 2D and 3D laparoscopic TME was performed (ISRCTN59485808). Trial surgeons were colorectal consultants that had completed their TME proficiency curve and underwent stereoscopic visual testing. Patients requiring elective laparoscopic TME with curative intent were centrally randomised (1:1) to 2D or 3D using Karl Storz IMAGE1 S D3-Link™ and 10-mm TIPCAM®1S 3D passive polarising laparoscopic systems. Outcomes were enacted adverse events as assessed by the observational clinical human reliability analysis technique, intraoperative data, 30-day patient outcomes, histopathological specimen assessment and surgeon cognitive load. Results 88 patients were included. There were no differences in patient or tumour demographics, surgeon stereopsis, case difficulty, cognitive load, operative time, blood loss or conversion between the trial arms. 1377 intraoperative adverse events were identified (median 18 per case, IQR 14–21, range 2–49) with no differences seen between the 2D and 3D arms (18 (95% CI 17–21) vs. 17 (95% CI 16–19), p = 0.437). 3D laparoscopy had non-significantly higher mesorectal fascial plane resections (94 vs. 77%, p = 0.059; OR 0.23 (95% CI 0.05–1.16)) but equal lymph node yield and circumferential margin distance and involvement. 30-day morbidity, anastomotic leak, re-operation, length of stay and readmission rates were equal between the 2D and 3D arms. Conclusion Feasibility of performing multicentre 3D laparoscopic multicentre trials of specialist performed complex procedures is shown. 3D imaging did not alter the number of intraoperative adverse events; however, a potential improvement in mesorectal specimen quality was observed and should form the focus of future 3D laparoscopic TME trials.
Issue Date: 1-Oct-2019
Date of Acceptance: 17-Dec-2018
URI: http://hdl.handle.net/10044/1/73772
DOI: https://doi.org/10.1007/s00464-018-06630-9
ISSN: 0930-2794
Publisher: Springer Verlag
Start Page: 3370
End Page: 3383
Journal / Book Title: SURGICAL ENDOSCOPY AND OTHER INTERVENTIONAL TECHNIQUES
Volume: 33
Issue: 10
Copyright Statement: © The Author(s) 2019. 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.
Keywords: Science & Technology
Life Sciences & Biomedicine
Surgery
3D
Three-dimensional
Laparoscopic
Rectal cancer
Total mesorectal excision
Trial
RELIABILITY-ANALYSIS OCHRA
LOW-RECTAL-CANCER
COLORECTAL SURGERY
SURGICAL COMPLICATIONS
PATHOLOGICAL OUTCOMES
ASSISTED RESECTION
OPEN-LABEL
CHEMORADIOTHERAPY
QUALITY
CLASSIFICATION
3D
Laparoscopic
Rectal cancer
Three-dimensional
Total mesorectal excision
Trial
Science & Technology
Life Sciences & Biomedicine
Surgery
3D
Three-dimensional
Laparoscopic
Rectal cancer
Total mesorectal excision
Trial
RELIABILITY-ANALYSIS OCHRA
LOW-RECTAL-CANCER
COLORECTAL SURGERY
SURGICAL COMPLICATIONS
PATHOLOGICAL OUTCOMES
ASSISTED RESECTION
OPEN-LABEL
CHEMORADIOTHERAPY
QUALITY
CLASSIFICATION
Surgery
1103 Clinical Sciences
Publication Status: Accepted
Online Publication Date: 2019-01-17
Appears in Collections:Department of Surgery and Cancer