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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04013152
Other study ID # PROICM 2017-05 ROB
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date June 13, 2018
Est. completion date June 9, 2027

Study information

Verified date January 2024
Source Institut du Cancer de Montpellier - Val d'Aurelle
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Description:

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Study Design


Intervention

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

Locations

Country Name City State
France CHU de Bordeaux Bordeaux Gironde
France CHU de Clermont-Ferrand Clermont-Ferrand Puy De Dôme
France CHU de Lyon Lyon Rhône
France Institut régional du cancer de Montpellier Montpellier Hérault

Sponsors (1)

Lead Sponsor Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

References & Publications (11)

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Outcome

Type Measure Description Time frame Safety issue
Primary Collection of clinical data following surgery with robotic assistance in colorectal pathologies 3 years
Secondary Time of learning for each surgical technique by determining a learning curve for each of them 3 years
Secondary The conversion rate of surgical technique 3 years
Secondary Operating time 3 years
Secondary Intraoperative complications rate 3 years
Secondary Duration of hospital stay 1 month
Secondary local relapse-free survival 8 years
Secondary overall survival 8 years
Secondary 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) 3 years
Secondary 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) 3 years
Secondary 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). 3 years
Secondary Urinary functionality by using the questionnaire of urinary function The range is from 0 (low urinary function) to 40 (high urinary function). 3 years
Secondary Objective surgeon performance metrics using a novel recorder (dVLogger) to directly capture surgeon manipulations on the da Vinci Surgical System 3 years
Secondary Number of lymph node resected 3 years
Secondary 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 . 3 years
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