Assisted Promontofixation Using Glue Versus Promontofixation Using Threads (PROCOL)

Not Applicable

Completed

• Conditions: Prolapse
• Interventions: Procedure: Laparostopic promontofixation using surgical glue; Procedure: Laparostopic promontofixation using threads

• Registration Number: NCT03624764
• Lead Sponsor: Clinique Beau Soleil

Brief 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.

Study Timeline

• Study Start: 2017-01-04
• Study First Submitted: 2018-06-19
• Study First Submitted QC: 2018-08-07
• Study First Posted: 2018-08-10
• Primary Completion: 2019-10-04
• Study Completion: 2020-01-04
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-08
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

1. Age> 40 years
2. Surgical indication of prolapse cure by promontofixation
3. Valid social insurance
4. French spoken and written
5. Informed consent signed
6. No exclusion criteria

Exclusion Criteria

1. Concomitant rectopexy
2. Concomitant Hysterectomy
3. Associated surgical procedure not compatible with measurement of operative time
4. Refusal to participate in the study
5. Pregnant or lactating woman (Article L 1121-5 of the french code of public health)
6. Vulnerable persons (Article L 1121-6 of the french code of public health)
7. Majors subject to legal protection or unable to express their consent (Article 1121-8 of the CSP)
8. Participation in another protocol for less than 3 months
9. Patient does not have all the inclusion criteria.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Promontofixation using glue	Laparostopic promontofixation using surgical glue	Patients in this arm will have a laparoscopic promontofixation using a biocompatible cyanoacrylate adhesive replacing some sutures to maintain the strips.
Promontofixation using threads	Laparostopic promontofixation using threads	Patients in this arm will have a laparoscopic promontofixation using sutures with threads to maintain the strips.

Primary Outcome Measures

Name	Time	Method
Operative time	one day	The time elapsed between incision and closure

Secondary Outcome Measures

Name	Time	Method
Collection of intra-operative complications	one day	Collection of all the complications during the surgery (visceral wound, peroperative bleeding, other)
Collection of per-operative complications	one day	Collection of the per-operative complications: pain at day 0 and day 1 (using the visual analog scale), urinary retention, postoperative haemorrhage or hematoma, fever\> 38 ° 48 h after surgery, other complication
Collection of complications at 6 weeks	6 weeks	Pain by the Visuel Analog Scale, emergency consultation or generalist, rehospitalization / Reintervention, other complications
Tolerance of the prosthesis	12 months	Classification of the complications related to the insertion of protheses (from the International Urogynecological Association)
Objective anatomical results at 6 weeks	Before surgery	International Continence Society - Pelvic organe Prolapse - Quantification (POP Q scale): stage 0 (no prolapse is demonstrated) to stage 4 (vaginal eversion is essentially complete)
Objective anatomical results at 6 months	6 months after surgery	International Continence Society - Pelvic organe Prolapse - Quantification (POP Q scale): stage 0 (no prolapse is demonstrated) to stage 4 (vaginal eversion is essentially complete)
Objective anatomical results at 12 month	12 months after surgery	International Continence Society - Pelvic organe Prolapse - Quantification (POP Q scale): stage 0 (no prolapse is demonstrated) to stage 4 (vaginal eversion is essentially complete)
Quality of life: pelvic floor distress	12 months after the surgery	The Pelvic Floor Distress Inventory-20 questionnary. The PFDI-20 includes 20 questions and 3 scales. Each of the 3 scales is scored from 0 (least distress) to 100 (greatest distress). The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 - 300. The 3 scales include questions taken from the following widely used outcome measures: Urinary Distress Inventory - 6 questions, Pelvic Organ Prolapse Distress Inventory - 6 questions, and Colorectal-Anal Distress Inventory - 8 questions

Trial Locations

Locations (1)

Clinique Beau Soleil; 🇫🇷 Montpellier, France