Assisted Promontofixation Using Glue Versus Promontofixation Using Threads (PROCOL) (PROCOL)

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

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

Study Overview

• Status: Completed
• Conditions: Prolapse
• Intervention / Treatment: Procedure: Laparostopic promontofixation using surgical glue; Procedure: Laparostopic promontofixation using threads

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34070
    • Clinique Beau Soleil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Promontofixation using glue; Patients in this arm will have a laparoscopic promontofixation using a biocompatible cyanoacrylate adhesive replacing some sutures to maintain the strips.	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)
Active Comparator: Promontofixation using threads; Patients in this arm will have a laparoscopic promontofixation using sutures with threads to maintain the strips.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	The time elapsed between incision and closure	one day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collection of intra-operative complications	Collection of all the complications during the surgery (visceral wound, peroperative bleeding, other)	one day
Collection of per-operative complications	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	one day
Collection of complications at 6 weeks	Pain by the Visuel Analog Scale, emergency consultation or generalist, rehospitalization / Reintervention, other complications	6 weeks
Tolerance of the prosthesis	Classification of the complications related to the insertion of protheses (from the International Urogynecological Association)	6 weeks
Tolerance of the prosthesis	Classification of the complications related to the insertion of protheses (from the International Urogynecological Association)	6 months
Tolerance of the prosthesis	Classification of the complications related to the insertion of protheses (from the International Urogynecological Association)	12 months
Objective anatomical results at 6 weeks	International Continence Society - Pelvic organe Prolapse - Quantification (POP Q scale): stage 0 (no prolapse is demonstrated) to stage 4 (vaginal eversion is essentially complete)	Before surgery
Objective anatomical results at 6 months	International Continence Society - Pelvic organe Prolapse - Quantification (POP Q scale): stage 0 (no prolapse is demonstrated) to stage 4 (vaginal eversion is essentially complete)	6 months after surgery
Objective anatomical results at 12 month	International Continence Society - Pelvic organe Prolapse - Quantification (POP Q scale): stage 0 (no prolapse is demonstrated) to stage 4 (vaginal eversion is essentially complete)	12 months after surgery
Quality of life: pelvic floor distress	The Pelvic Floor Distress Inventory-20 questionnary: it is both a symptom inventory and a measure of the degree of bother and distress (quality-of-life) caused by pelvic floor symptoms.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	Before the surgery
Quality of life: pelvic floor distress	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	6 months after the surgery
Quality of life: pelvic floor distress	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	12 months after the surgery

Collaborators and Investigators

• Sponsor: Clinique Beau Soleil
• Investigators: Principal Investigator: Christophe Courtieu, Clinqieu Beau Soleil

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2017
• Primary Completion (Actual): October 4, 2019
• Study Completion (Actual): January 4, 2020

Study Registration Dates

• First Submitted: June 19, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: prolapse surgery; promontofixation
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse
• Other Study ID Numbers: 2016- A01387-44

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No