ROBOT CR: Clinical Database of Colorectal Robotic Surgery

Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle (Other)
Overall Status
Recruiting
CT.gov ID
NCT04013152
Collaborator
(none)
1,800
4
1
90.6
450
5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Clinical database
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
1800 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
French Prospective Clinical Database of Colorectal Robotic Surgery
Actual Study Start Date :
Jun 13, 2018
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
Jan 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: clinical database

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

Outcome Measures

Primary Outcome Measures

  1. Collection of clinical data following surgery with robotic assistance in colorectal pathologies [3 years]

Secondary Outcome Measures

  1. Time of learning for each surgical technique by determining a learning curve for each of them [3 years]

  2. The conversion rate of surgical technique [3 years]

  3. Operating time [3 years]

  4. Intraoperative complications rate [3 years]

  5. Duration of hospital stay [1 month]

  6. local relapse-free survival [8 years]

  7. overall survival [8 years]

  8. Digestive functionality assessment by using the Low Anterior Resection Syndrome score (LARS) [3 years]

    This questionnaire assessed the bowel function of patient. The range is from 8 (low function) to 35 (high function)

  9. The Erectile Function of patient by using the II-EF-5 score (The International Index of Erectile Function) [3 years]

    The range is from 1 (low erectile function) to 27 (high erectile function)

  10. The dysfunction of female Sexual Function by using the Index FSFI (The Female Sexual Function Index) score [3 years]

    The range is from 3 (low sexual function) to 55 (high sexual function).

  11. Urinary functionality by using the questionnaire of urinary function [3 years]

    The range is from 0 (low urinary function) to 40 (high urinary function).

  12. Objective surgeon performance metrics using a novel recorder (dVLogger) to directly capture surgeon manipulations on the da Vinci Surgical System [3 years]

  13. Number of lymph node resected [3 years]

  14. Quality of the mesorectum by using Quirke classification [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 .

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Bordeaux Bordeaux Gironde France 33600
2 Institut régional du cancer de Montpellier Montpellier Hérault France 34298
3 CHU de Clermont-Ferrand Clermont-Ferrand Puy De Dôme France 63103
4 CHU de Lyon Lyon Rhône France 69310

Sponsors and Collaborators

  • Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Institut du Cancer de Montpellier - Val d'Aurelle
ClinicalTrials.gov Identifier:
NCT04013152
Other Study ID Numbers:
  • PROICM 2017-05 ROB
First Posted:
Jul 9, 2019
Last Update Posted:
Mar 14, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Institut du Cancer de Montpellier - Val d'Aurelle
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 14, 2022