Clinical trial · Observational
Clinical Database of Colorectal Robotic Surgery
French Prospective Clinical Database of Colorectal Robotic Surgery
NCT04013152CI-TRIAL-00085844ROBOT CRactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Colorectal Tumor | Benign Colorectal Neoplasm | ALIAS | 0.90 |
| Colorectal Tumor | Colorectal Neoplasm | ALIAS | 0.90 |
| Crohn Disease | — | UNRESOLVED | — |
| Diverticulitis | — | UNRESOLVED | — |
| Polyposis | Polyposis | ONTOLOGY_EXACT | 0.98 |
| Rectal Prolapse | — | UNRESOLVED | — |
| Ulcerative Colitis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clinical database | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- clinical database
- interventionNames
- Other: Clinical database
Primary outcomes (1)
- measure
- Collection of clinical data following surgery with robotic assistance in colorectal pathologies
- timeFrame
- 3 years
Secondary outcomes (14)
- measure
- Time of learning for each surgical technique by determining a learning curve for each of them
- timeFrame
- 3 years
- measure
- The conversion rate of surgical technique
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (11)
- BACKGROUNDColombo 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
- BACKGROUNDBertrand 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
- BACKGROUNDNagtegaal 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
- BACKGROUNDChen 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
- BACKGROUNDZhang 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
- BACKGROUNDParc 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