NCT03624764

Assisted Promontofixation Using Glue Versus Promontofixation Using Threads (PROCOL)

A Randomized Comparative Study of Assisted Promontofixation Using Glue Versus Promontofixation Using Threads

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Clinique Beau Soleil · Academic / Other
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The treatment of gynecological prolapse (organ removal) can be done by laparoscopy or vaginally. Laparoscopy is used in 1 out of 2 cases, but learning is difficult and operation time is long. One of the technical difficulties is related to the sutures to the threads. Some surgeons therefore use a glue to fix prosthetic reinforcements more easily and quickly, but this sizing technique has only been evaluated very little. Our study proposes to compare the technique of suture with the thread at the gluing of the prostheses in order to validate the merits of this new technique

Detailed description

Laparoscopic promontofixation is a surgical technique considered by some as the reference technique. Its difficulty of learning and the duration of operation are factors limiting its diffusion. The use of cyanoacrylate glue is proposed to simplify the procedure, without there being any comparative studies between the sutures over and the sizing of prosthetic reinforcements. The main objective of the study is to compare the operative time of promontofixation by coelioscopy with suture using threads to promontofixation using glue. Secondary objectives are the comparison between the two groups of complications per and postoperative, objective anatomical results and functional results of the tissue reaction judged by clinical examination (palpation) and ultrasound and direct cost.

Conditions

• Prolapse

Interventions

Type	Name	Description
PROCEDURE	Laparostopic promontofixation using surgical glue	The technique involves implanting a prosthetic tissue (tape) between the bladder and the vagina, suspending the cervix or the vagina affectionately, associated or not with a posterior strip placed between the rectum and the vagina fixed on the small pelvis muscles. Each strip is held by the surgical glue (cyanoacrylate biocompatible adhesive)
PROCEDURE	Laparostopic promontofixation using threads	The technique involves implanting a prosthetic tissue (tape) between the bladder and the vagina, suspending the cervix or the vagina affectionately, associated or not with a posterior strip placed between the rectum and the vagina fixed on the small pelvis muscles. Each strip is held by sutures with threads

Timeline

• Start date: 2017-01-04
• Primary completion: 2019-10-04
• Completion: 2020-01-04
• First posted: 2018-08-10
• Last updated: 2021-02-09

Locations

1 site across 1 country: France