Clinical Database of Colorectal Robotic Surgery (ROBOT CR)

• ClinicalTrials.gov Identifier: NCT04013152
• Recruitment Status: Active, not recruiting
• First Posted: July 9, 2019
• Last Update Posted: January 26, 2024
• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
• Information provided by (Responsible Party): Institut du Cancer de Montpellier - Val d'Aurelle

Tracking Information

• First Submitted Date: July 4, 2019
• First Posted Date: July 9, 2019
• Last Update Posted Date: January 26, 2024
• Actual Study Start Date: June 13, 2018
• Actual Primary Completion Date: June 9, 2022 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 5, 2019): Collection of clinical data following surgery with robotic assistance in colorectal pathologies [ Time Frame: 3 years ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 5, 2019)

• Time of learning for each surgical technique by determining a learning curve for each of them [ Time Frame: 3 years ]
• The conversion rate of surgical technique [ Time Frame: 3 years ]
• Operating time [ Time Frame: 3 years ]
• Intraoperative complications rate [ Time Frame: 3 years ]
• Duration of hospital stay [ Time Frame: 1 month ]
• local relapse-free survival [ Time Frame: 8 years ]
• overall survival [ Time Frame: 8 years ]
• Digestive functionality assessment by using the Low Anterior Resection Syndrome score (LARS) [ Time Frame: 3 years ]
  This questionnaire assessed the bowel function of patient. The range is from 8 (low function) to 35 (high function)
• The Erectile Function of patient by using the II-EF-5 score (The International Index of Erectile Function) [ Time Frame: 3 years ]
  The range is from 1 (low erectile function) to 27 (high erectile function)
• The dysfunction of female Sexual Function by using the Index FSFI (The Female Sexual Function Index) score [ Time Frame: 3 years ]
  The range is from 3 (low sexual function) to 55 (high sexual function).
• Urinary functionality by using the questionnaire of urinary function [ Time Frame: 3 years ]
  The range is from 0 (low urinary function) to 40 (high urinary function).
• Objective surgeon performance metrics using a novel recorder (dVLogger) to directly capture surgeon manipulations on the da Vinci Surgical System [ Time Frame: 3 years ]
• Number of lymph node resected [ Time Frame: 3 years ]
• Quality of the mesorectum by using Quirke classification [ Time Frame: 3 years ]
  The quality of the mesorectum resection is determined by the pathologist according to the aspect of mesorectum, the circumferential resection margin, cone effect .

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Clinical Database of Colorectal Robotic Surgery
• Official Title: French Prospective Clinical Database of Colorectal Robotic Surgery
• Brief Summary: Evaluation of robot Da Vinci Xi by determining its learning curve.The operating time will be defined by patient then the operating average will be calculated.

Detailed Description

Since the emergence of minimally invasive technology twenty years ago, as a surgical concept and surgical technique for colorectal cancer surgery, its obvious advantages have been recognized.

Laparoscopic technology, as one of the most important technology platform, has got a lot of evidence-based support for the oncological safety and effectiveness in colorectal cancer surgery Laparoscopic technique has advantages in terms of identification of anatomic plane and autonomic nerve, protection of pelvic structure, and fine dissection of vessels.

But because of the limitation of laparoscopic technology there are still some deficiencies and shortcomings, including lack of touch and lack of stereo vision problems, in addition to the low rectal cancer, especially male, obese, narrow pelvis, larger tumors, it is difficult to get better view and manipulating triangle in laparoscopy. However, the emergence of a series of new minimally invasive technology platform is to make up for the defects and deficiencies. The robotic surgical system possesses advantages, such as stereo vision, higher magnification, manipulator wrist with high freedom degree, filtering of tremor and higher stability, but still has disadvantages, such as lack of haptic feedback, longer operation time, high operation cost and expensive price.

3D system of laparoscopic surgery has similar visual experience and feelings as robotic surgery in the 3D view, the same operating skills as 2D laparoscopy and a short learning curve. Transanal total mesorectal excision (taTME) by changing the traditional laparoscopic pelvic surgery approach, may have certain advantages for male cases with narrow pelvic and patients with large tumor.

No prospective study has compared these four surgical techniques. Furthermore, the learning curve still remains a crucial problem in term of data interpretation.

We will collect synchronized videos and data on surgeon performance during colorectal surgeries using the Vinci Logger (dVLogger, Intuitive Surgical, Inc.), it is a personalized recording tool that captures synchronized video in the form of endoscope view at 30 frames per second. Kinematic data included characteristics of movement such as instrument travel time, path length and velocity. Events included frequency of master controller clutch use, camera movements, third arm swap and energy use.

We will explore and validate objective surgeon performance metrics using novel recorder ("dVLogger") to directly capture surgeon manipulations on the daVinci Surgical System.

• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Other; Time Perspective: Prospective
• Target Follow-Up Duration: 5 Years
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Colorectal tumor, Crohn's disease, Polyposis, Ulcerative colitis, Diverticulitis, Rectal prolapse, Benign colorectal tumor

Condition

• Crohn Disease
• Polyposis
• Ulcerative Colitis
• Diverticulitis
• Colorectal Tumor
• Rectal Prolapse
• Benign Colorectal Tumor

Intervention

Other: Clinical database

Constitution of a prospective, multicenter clinical database of surgery with robotic assistance in colorectal pathologies

Study Groups/Cohorts

clinical database

Intervention: Other: Clinical database

Publications *

• Colombo PE, Bertrand MM, Alline M, Boulay E, Mourregot A, Carrere S, Quenet F, Jarlier M, Rouanet P. Robotic Versus Laparoscopic Total Mesorectal Excision (TME) for Sphincter-Saving Surgery: Is There Any Difference in the Transanal TME Rectal Approach? : A Single-Center Series of 120 Consecutive Patients. Ann Surg Oncol. 2016 May;23(5):1594-600. doi: 10.1245/s10434-015-5048-4. Epub 2015 Dec 29.
• Bertrand MM, Colombo PE, Mourregot A, Traore D, Carrere S, Quenet F, Rouanet P. Standardized single docking, four arms and fully robotic proctectomy for rectal cancer: the key points are the ports and arms placement. J Robot Surg. 2016 Jun;10(2):171-4. doi: 10.1007/s11701-015-0551-y. Epub 2015 Dec 8.
• Nagtegaal ID, van de Velde CJ, van der Worp E, Kapiteijn E, Quirke P, van Krieken JH; Cooperative Clinical Investigators of the Dutch Colorectal Cancer Group. Macroscopic evaluation of rectal cancer resection specimen: clinical significance of the pathologist in quality control. J Clin Oncol. 2002 Apr 1;20(7):1729-34. doi: 10.1200/JCO.2002.07.010.
• Chen SL, Steele SR, Eberhardt J, Zhu K, Bilchik A, Stojadinovic A. Lymph node ratio as a quality and prognostic indicator in stage III colon cancer. Ann Surg. 2011 Jan;253(1):82-7. doi: 10.1097/SLA.0b013e3181ffa780.
• Zhang X, Wei Z, Bie M, Peng X, Chen C. Robot-assisted versus laparoscopic-assisted surgery for colorectal cancer: a meta-analysis. Surg Endosc. 2016 Dec;30(12):5601-5614. doi: 10.1007/s00464-016-4892-z. Epub 2016 Jul 11.
• Parc Y, Reboul-Marty J, Lefevre JH, Shields C, Chafai N, Tiret E. Factors influencing mortality and morbidity following colorectal resection in France. Analysis of a national database (2009-2011). Colorectal Dis. 2016 Feb;18(2):205-13. doi: 10.1111/codi.13099.
• Bege T, Lelong B, Esterni B, Turrini O, Guiramand J, Francon D, Mokart D, Houvenaeghel G, Giovannini M, Delpero JR. The learning curve for the laparoscopic approach to conservative mesorectal excision for rectal cancer: lessons drawn from a single institution's experience. Ann Surg. 2010 Feb;251(2):249-53. doi: 10.1097/SLA.0b013e3181b7fdb0.
• Poloniecki J, Valencia O, Littlejohns P. Cumulative risk adjusted mortality chart for detecting changes in death rate: observational study of heart surgery. BMJ. 1998 Jun 6;316(7146):1697-700. doi: 10.1136/bmj.316.7146.1697. Erratum In: BMJ 1998 Jun 27;316(7149):1947.
• Guend H, Widmar M, Patel S, Nash GM, Paty PB, Guillem JG, Temple LK, Garcia-Aguilar J, Weiser MR. Developing a robotic colorectal cancer surgery program: understanding institutional and individual learning curves. Surg Endosc. 2017 Jul;31(7):2820-2828. doi: 10.1007/s00464-016-5292-0. Epub 2016 Nov 4.
• Bokhari MB, Patel CB, Ramos-Valadez DI, Ragupathi M, Haas EM. Learning curve for robotic-assisted laparoscopic colorectal surgery. Surg Endosc. 2011 Mar;25(3):855-60. doi: 10.1007/s00464-010-1281-x. Epub 2010 Aug 24.
• Bolsin S, Colson M. The use of the Cusum technique in the assessment of trainee competence in new procedures. Int J Qual Health Care. 2000 Oct;12(5):433-8. doi: 10.1093/intqhc/12.5.433.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: July 5, 2019): 1800
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 9, 2027
• Actual Primary Completion Date: June 9, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Male or female ≥ 18 years
2. Colorectal pathologies (Crohn's disease, Polyposis, Ulcerative colitis, Diverticulitis, Colorectal tumor, Rectal prolapse, Benign and colorectal tumor) eligible for robotic surgery.
3. Major techniques: right and left colectomy, rectal excision (low anterior resection, intersphincteric resection, abdominoperineal resection), Hartman reversal
4. Or, Minor techniques: rectopexy, shaving for rectal endometriosis,
5. Or, Complex techniques: extended rectal excision for T4 cancer, pelvectomy, redo surgery.
6. Patient affiliated to a social security regimen
7. Patient information for study

Exclusion Criteria:

1. Legal incapacity or physical, psychological social or geographical status interfering with the patient's ability to agree to participate in the study
2. Patient under tutelage, curatorship or safeguard of justice

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT04013152
• Other Study ID Numbers: PROICM 2017-05 ROB
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Institut du Cancer de Montpellier - Val d'Aurelle
• Original Responsible Party: Same as current
• Current Study Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Philippe Rouanet, MD; Institut régional du cancer de Montpellier

• PRS Account: Institut du Cancer de Montpellier - Val d'Aurelle
• Verification Date: January 2024