Clinical Database of Colorectal Robotic Surgery

NCT04013152 | Active Not Recruiting

• 1 other identifier: PROICM 2017-05 ROB
• Study Type: observational
• Target: 1,800
• Locations: 1 country
• Sites: 4

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.

Conditions

Crohn Disease; Polyposis; Ulcerative Colitis; Diverticulitis; Colorectal Tumor; Rectal Prolapse; Benign Colorectal Tumor

Keywords

CROHN; Diverticulitis; Rectal; colorectal; ulcerative; colitis; polyposis; rectum; prolapse

Outcome Measures

Primary Outcomes (1)

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

  3 years

Secondary Outcomes (14)

• Time of learning for each surgical technique by determining a learning curve for each of them

  3 years

• The conversion rate of surgical technique

  3 years

• Operating time

  3 years

• Intraoperative complications rate

  3 years

• Duration of hospital stay

  1 month

Study Arms (1)

clinical database

Other: Clinical database

Interventions

Clinical database OTHER

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

clinical database

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (4)

CHU de Bordeaux

Bordeaux, Gironde, 33600, France

Location

Institut régional du cancer de Montpellier

Montpellier, Hérault, 34298, France

Location

CHU de Clermont-Ferrand

Clermont-Ferrand, Puy De Dôme, 63103, France

Location

CHU de Lyon

Lyon, Rhône, 69310, France

Location

Related Publications (11)

• 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.

  PMID: 26714950 BACKGROUND

• 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.

  PMID: 26645073 BACKGROUND

• 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.

  PMID: 11919228 BACKGROUND

• 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.

  PMID: 21135690 BACKGROUND

• 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.

  PMID: 27402096 BACKGROUND

• 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.

  PMID: 26299627 BACKGROUND

• 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.

  PMID: 20040854 BACKGROUND

• 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.

  PMID: 9614015 BACKGROUND

• 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.

  PMID: 27815742 BACKGROUND

• 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.

  PMID: 20734081 BACKGROUND

• 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.

  PMID: 11079224 BACKGROUND

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Diverticulitis; Colorectal Neoplasms; Rectal Prolapse; Ulcer; Colitis; Prolapse

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colonic Diseases; Diverticular Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Rectal Diseases; Pelvic Organ Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Philippe Rouanet, MD

  Institut régional du cancer de Montpellier

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: July 9, 2019
• Study Start: June 13, 2018
• Primary Completion: June 9, 2022
• Study Completion (Estimated): June 9, 2027
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)