Clinical Database of Colorectal Robotic Surgery (ROBOT CR)
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| ClinicalTrials.gov Identifier: NCT04013152 |
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Recruitment Status :
Active, not recruiting
First Posted : July 9, 2019
Last Update Posted : January 26, 2024
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| Condition or disease | Intervention/treatment |
|---|---|
| Crohn Disease Polyposis Ulcerative Colitis Diverticulitis Colorectal Tumor Rectal Prolapse Benign Colorectal Tumor | Other: Clinical database |
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] |
| Actual Enrollment : | 1800 participants |
| Observational Model: | Other |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 5 Years |
| Official Title: | French Prospective Clinical Database of Colorectal Robotic Surgery |
| Actual Study Start Date : | June 13, 2018 |
| Actual Primary Completion Date : | June 9, 2022 |
| Estimated Study Completion Date : | June 9, 2027 |
| Group/Cohort | Intervention/treatment |
|---|---|
| clinical database |
Other: Clinical database
Constitution of a prospective, multicenter clinical database of surgery with robotic assistance in colorectal pathologies |
- Collection of clinical data following surgery with robotic assistance in colorectal pathologies [ Time Frame: 3 years ]
- 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 .
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04013152
| France | |
| CHU de Bordeaux | |
| Bordeaux, Gironde, France, 33600 | |
| Institut régional du cancer de Montpellier | |
| Montpellier, Hérault, France, 34298 | |
| CHU de Clermont-Ferrand | |
| Clermont-Ferrand, Puy De Dôme, France, 63103 | |
| CHU de Lyon | |
| Lyon, Rhône, France, 69310 | |
| Study Chair: | Philippe Rouanet, MD | Institut régional du cancer de Montpellier |
| Responsible Party: | Institut du Cancer de Montpellier - Val d'Aurelle |
| ClinicalTrials.gov Identifier: | NCT04013152 |
| Other Study ID Numbers: |
PROICM 2017-05 ROB |
| First Posted: | July 9, 2019 Key Record Dates |
| Last Update Posted: | January 26, 2024 |
| Last Verified: | January 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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CROHN Diverticulitis Rectal colorectal ulcerative |
colitis polyposis rectum prolapse |
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Colorectal Neoplasms Crohn Disease Colitis Diverticulitis Rectal Prolapse Prolapse Neoplasms Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
Intestinal Diseases Colonic Diseases Pathological Conditions, Anatomical Diverticular Diseases Rectal Diseases Pelvic Organ Prolapse Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |