Clinical Database of Colorectal Robotic Surgery (ROBOT CR)

February 11, 2025 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

French Prospective Clinical Database of Colorectal Robotic Surgery

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Enrollment (Actual)

1800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Gironde
      • Bordeaux, Gironde, France, 33600
        • CHU de Bordeaux
    • Hérault
      • Montpellier, Hérault, France, 34298
        • Institut Regional Du Cancer de Montpellier
    • Puy De Dôme
      • Clermont-Ferrand, Puy De Dôme, France, 63103
        • CHU de Clermont-Ferrand
    • Rhône
      • Lyon, Rhône, France, 69310
        • CHU de Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Colorectal tumor, Crohn's disease, Polyposis, Ulcerative colitis, Diverticulitis, Rectal prolapse, Benign colorectal tumor

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
clinical database
Other: Clinical database
Constitution of a prospective, multicenter clinical database of surgery with robotic assistance in colorectal pathologies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Collection of clinical data following surgery with robotic assistance in colorectal pathologies
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 8 years
8 years
Time of learning for each surgical technique by determining a learning curve for each of them
Time Frame: 3 years
3 years
The conversion rate of surgical technique
Time Frame: 3 years
3 years
Operating time
Time Frame: 3 years
3 years
Intraoperative complications rate
Time Frame: 3 years
3 years
Duration of hospital stay
Time Frame: 1 month
1 month
local relapse-free survival
Time Frame: 8 years
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)
3 years
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)
3 years
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).
3 years
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).
3 years
Objective surgeon performance metrics using a novel recorder (dVLogger) to directly capture surgeon manipulations on the da Vinci Surgical System
Time Frame: 3 years
3 years
Number of lymph node resected
Time Frame: 3 years
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 .
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

  • Study Chair: Philippe Rouanet, MD, Institut Regional Du Cancer de Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2018

Primary Completion (Actual)

June 9, 2022

Study Completion (Estimated)

June 9, 2027

Study Registration Dates

First Submitted

July 4, 2019

First Submitted That Met QC Criteria

July 5, 2019

First Posted (Actual)

July 9, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 11, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROICM 2017-05 ROB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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