Clinical trial NCT04013152: Clinical Database of Colorectal Robotic Surgery
Official title: French Prospective Clinical Database of Colorectal Robotic Surgery
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Crohn Disease
Polyposis
Ulcerative Colitis
Diverticulitis
Colorectal Tumor
Rectal Prolapse
Benign Colorectal Tumor
Keywords: CROHN
Diverticulitis
Rectal
colorectal
ulcerative
colitis
polyposis
rectum
prolapse
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Colorectal tumor, Crohn's disease, Polyposis, Ulcerative colitis, Diverticulitis, Rectal prolapse, Benign colorectal tumor

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Collection of clinical data following surgery with robotic assistance in colorectal pathologies
timeFrame: 3 years
Secondary outcomes:
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
measure: Operating time
timeFrame: 3 years
measure: Intraoperative complications rate
timeFrame: 3 years
measure: Duration of hospital stay
timeFrame: 1 month
measure: local relapse-free survival
timeFrame: 8 years
measure: overall survival
timeFrame: 8 years
measure: Digestive functionality assessment by using the Low Anterior Resection Syndrome score (LARS)
timeFrame: 3 years
measure: The Erectile Function of patient by using the II-EF-5 score (The International Index of Erectile Function)
timeFrame: 3 years
measure: The dysfunction of female Sexual Function by using the Index FSFI (The Female Sexual Function Index) score
timeFrame: 3 years
measure: Urinary functionality by using the questionnaire of urinary function
timeFrame: 3 years
measure: Objective surgeon performance metrics using a novel recorder (dVLogger) to directly capture surgeon manipulations on the da Vinci Surgical System
timeFrame: 3 years
measure: Number of lymph node resected
timeFrame: 3 years
measure: Quality of the mesorectum by using Quirke classification
timeFrame: 3 years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
state: Gironde
city: Montpellier
country: France
facility: Institut régional du cancer de Montpellier
state: Hérault
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
state: Puy De Dôme
city: Lyon
country: France
facility: CHU de Lyon
state: Rhône
Study officials:
affiliation: Institut régional du cancer de Montpellier
name: Philippe Rouanet, MD
role: STUDY_CHAIR
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