Suspended

ROBOT CRFrench Prospective Clinical Database of Colorectal Robotic Surgery

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Diverticular Diseases+22

+ Colitis

+ Colitis, Ulcerative

Over 18 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other

Utilizing specific methods not covered by standard models in order to address unique research questions.
Observational
Study Start: June 2018
See protocol details

Summary

Principal SponsorInstitut du Cancer de Montpellier - Val d'Aurelle
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 13, 2018

Actual date on which the first participant was enrolled.

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.

Official TitleFrench Prospective Clinical Database of Colorectal Robotic Surgery
NCT04013152
Principal SponsorInstitut du Cancer de Montpellier - Val d'Aurelle
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

1800 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other

Some studies use unique or mixed approaches that don't fit standard categories. These may include innovative observational methods or studies tailored to specific research questions.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diverticular DiseasesColitisColitis, UlcerativeColonic DiseasesCrohn DiseaseDigestive System DiseasesDigestive System NeoplasmsDiverticulitisGastroenteritisGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsNeoplasmsNeoplasms by SitePathologic ProcessesProlapseRectal DiseasesRectal ProlapsePathological Conditions, Signs and SymptomsUlcerColorectal NeoplasmsInflammatory Bowel DiseasesPathological Conditions, AnatomicalPelvic Organ Prolapse

Criteria

7 inclusion criteria required to participate
Male or female ≥ 18 years

Or, Minor techniques: rectopexy, shaving for rectal endometriosis,

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

Show More Criteria

2 exclusion criteria prevent from participating
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Suspended

CHU de Bordeaux

Bordeaux, FranceOpen CHU de Bordeaux in Google Maps
Suspended

Institut régional du cancer de Montpellier

Montpellier, France
Suspended

CHU de Clermont-Ferrand

Clermont-Ferrand, France
Suspended

CHU de Lyon

Lyon, France
Suspended4 Study Centers
ROBOT CR | French Prospective Clinical Database of Colorectal Robotic Surgery | PatLynk