Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
1800 participants
OBSERVATIONAL
2018-06-13
2027-06-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Robotic Low Rectum Anterior Resection
NCT04015804
Robotic Assisted Right Colectomy With the DEXTER Robotic Surgery System
NCT07123051
The Clinical Study of Making the Evidence With Application of Da Vinci-Robot Assisted Low Anterior Resection in Rectal Cancer
NCT01125111
Comparison Between Colorectal Stents and Primary Surgery in Obstructive Colonic Cancer. A Randomized, Controlled Study
NCT00514332
Functional Status and Quality of Life in Older Patients Undergoing Robotic Surgery for Colorectal Cancer
NCT05848609
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
clinical database
Clinical database
Constitution of a prospective, multicenter clinical database of surgery with robotic assistance in colorectal pathologies
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Clinical database
Constitution of a prospective, multicenter clinical database of surgery with robotic assistance in colorectal pathologies
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
2. Patient under tutelage, curatorship or safeguard of justice
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Institut du Cancer de Montpellier - Val d'Aurelle
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Philippe Rouanet, MD
Role: STUDY_CHAIR
Institut régional du cancer de Montpellier
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU de Bordeaux
Bordeaux, Gironde, France
Institut régional du cancer de Montpellier
Montpellier, Hérault, France
CHU de Clermont-Ferrand
Clermont-Ferrand, Puy De Dôme, France
CHU de Lyon
Lyon, Rhône, France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PROICM 2017-05 ROB
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.