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Clinical Database of Colorectal Robotic Surgery (ROBOT CR)

Primary Purpose

Crohn Disease, Polyposis, Ulcerative Colitis

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Clinical database
Sponsored by
Institut du Cancer de Montpellier - Val d'Aurelle
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Crohn Disease focused on measuring CROHN, Diverticulitis, Rectal, colorectal, ulcerative, colitis, polyposis, rectum, prolapse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Bordeaux
  • Institut régional du cancer de Montpellier
  • CHU de Clermont-Ferrand
  • CHU de Lyon

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

clinical database

Arm Description

Outcomes

Primary Outcome Measures

Collection of clinical data following surgery with robotic assistance in colorectal pathologies

Secondary Outcome Measures

Time of learning for each surgical technique by determining a learning curve for each of them
The conversion rate of surgical technique
Operating time
Intraoperative complications rate
Duration of hospital stay
local relapse-free survival
overall survival
Digestive functionality assessment by using the Low Anterior Resection Syndrome score (LARS)
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)
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
The range is from 3 (low sexual function) to 55 (high sexual function).
Urinary functionality by using the questionnaire of urinary function
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
Number of lymph node resected
Quality of the mesorectum by using Quirke classification
The quality of the mesorectum resection is determined by the pathologist according to the aspect of mesorectum, the circumferential resection margin, cone effect .

Full Information

First Posted
July 4, 2019
Last Updated
November 16, 2022
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
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1. Study Identification

Unique Protocol Identification Number
NCT04013152
Brief Title
Clinical Database of Colorectal Robotic Surgery
Acronym
ROBOT CR
Official Title
French Prospective Clinical Database of Colorectal Robotic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 13, 2018 (Actual)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease, Polyposis, Ulcerative Colitis, Diverticulitis, Colorectal Tumor, Rectal Prolapse, Benign Colorectal Tumor
Keywords
CROHN, Diverticulitis, Rectal, colorectal, ulcerative, colitis, polyposis, rectum, prolapse

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1800 (Actual)

8. Arms, Groups, and Interventions

Arm Title
clinical database
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Clinical database
Intervention Description
Constitution of a prospective, multicenter clinical database of surgery with robotic assistance in colorectal pathologies
Primary Outcome Measure Information:
Title
Collection of clinical data following surgery with robotic assistance in colorectal pathologies
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Time of learning for each surgical technique by determining a learning curve for each of them
Time Frame
3 years
Title
The conversion rate of surgical technique
Time Frame
3 years
Title
Operating time
Time Frame
3 years
Title
Intraoperative complications rate
Time Frame
3 years
Title
Duration of hospital stay
Time Frame
1 month
Title
local relapse-free survival
Time Frame
8 years
Title
overall survival
Time Frame
8 years
Title
Digestive functionality assessment by using the Low Anterior Resection Syndrome score (LARS)
Description
This questionnaire assessed the bowel function of patient. The range is from 8 (low function) to 35 (high function)
Time Frame
3 years
Title
The Erectile Function of patient by using the II-EF-5 score (The International Index of Erectile Function)
Description
The range is from 1 (low erectile function) to 27 (high erectile function)
Time Frame
3 years
Title
The dysfunction of female Sexual Function by using the Index FSFI (The Female Sexual Function Index) score
Description
The range is from 3 (low sexual function) to 55 (high sexual function).
Time Frame
3 years
Title
Urinary functionality by using the questionnaire of urinary function
Description
The range is from 0 (low urinary function) to 40 (high urinary function).
Time Frame
3 years
Title
Objective surgeon performance metrics using a novel recorder (dVLogger) to directly capture surgeon manipulations on the da Vinci Surgical System
Time Frame
3 years
Title
Number of lymph node resected
Time Frame
3 years
Title
Quality of the mesorectum by using Quirke classification
Description
The quality of the mesorectum resection is determined by the pathologist according to the aspect of mesorectum, the circumferential resection margin, cone effect .
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female ≥ 18 years Colorectal pathologies (Crohn's disease, Polyposis, Ulcerative colitis, Diverticulitis, Colorectal tumor, Rectal prolapse, Benign and colorectal tumor) eligible for robotic surgery. Major techniques: right and left colectomy, rectal excision (low anterior resection, intersphincteric resection, abdominoperineal resection), Hartman reversal Or, Minor techniques: rectopexy, shaving for rectal endometriosis, Or, Complex techniques: extended rectal excision for T4 cancer, pelvectomy, redo surgery. Patient affiliated to a social security regimen Patient information for study Exclusion Criteria: Legal incapacity or physical, psychological social or geographical status interfering with the patient's ability to agree to participate in the study Patient under tutelage, curatorship or safeguard of justice
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Rouanet, MD
Organizational Affiliation
Institut régional du cancer de Montpellier
Official's Role
Study Chair
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
State/Province
Gironde
ZIP/Postal Code
33600
Country
France
Facility Name
Institut régional du cancer de Montpellier
City
Montpellier
State/Province
Hérault
ZIP/Postal Code
34298
Country
France
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
State/Province
Puy De Dôme
ZIP/Postal Code
63103
Country
France
Facility Name
CHU de Lyon
City
Lyon
State/Province
Rhône
ZIP/Postal Code
69310
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26714950
Citation
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.
Results Reference
background
PubMed Identifier
26645073
Citation
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.
Results Reference
background
PubMed Identifier
11919228
Citation
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.
Results Reference
background
PubMed Identifier
21135690
Citation
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.
Results Reference
background
PubMed Identifier
27402096
Citation
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.
Results Reference
background
PubMed Identifier
26299627
Citation
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.
Results Reference
background
PubMed Identifier
20040854
Citation
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.
Results Reference
background
PubMed Identifier
9614015
Citation
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.
Results Reference
background
PubMed Identifier
27815742
Citation
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.
Results Reference
background
PubMed Identifier
20734081
Citation
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.
Results Reference
background
PubMed Identifier
11079224
Citation
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.
Results Reference
background

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Clinical Database of Colorectal Robotic Surgery

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