An observational study in Crohn Disease, Polyposis and Ulcerative Colitis, sponsored by Institut du Cancer de Montpellier - Val d'Aurelle. Active, not recruiting at 4 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-12.
Sponsored by Institut du Cancer de Montpellier - Val d'Aurelle · Observational
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.
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.
1,992 studies on the registry are indexed under Crohn Disease; 478 are open to participants now.
This study's enrollment of 1,800 is above the median of 185 across 645 observational studies indexed under Crohn Disease.
Browse Crohn Disease studies →Institut du Cancer de Montpellier - Val d'Aurelle is the lead sponsor of 142 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Colorectal tumor, Crohn's disease, Polyposis, Ulcerative colitis, Diverticulitis, Rectal prolapse, Benign colorectal tumor
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Exclusion Criteria:
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)
This questionnaire assessed the bowel function of patient. The range is from 8 (low function) to 35 (high function)
Time frame: 3 years
The Erectile Function of patient by using the II-EF-5 score (The International Index of Erectile Function)
The range is from 1 (low erectile function) to 27 (high erectile function)
Time frame: 3 years
The dysfunction of female Sexual Function by using the Index FSFI (The Female Sexual Function Index) score
The range is from 3 (low sexual function) to 55 (high sexual function).
Time frame: 3 years
Urinary functionality by using the questionnaire of urinary function
The range is from 0 (low urinary function) to 40 (high urinary function).
Time frame: 3 years
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
The quality of the mesorectum resection is determined by the pathologist according to the aspect of mesorectum, the circumferential resection margin, cone effect .
Time frame: 3 years
Plan to share: No
Ran from Jun 2018 to primary completion in Jun 2022, 47 months.
Of 231 non-industry observational studies under Crohn Disease, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 101. This study's 47 months is close to that.
Counting every sponsor, half of 304 studies reached it within 42 months; a quarter within 29 and three quarters within 88.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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