Assisted Promontofixation Using Glue Versus Promontofixation Using Threads (PROCOL)

Prolapse Clinical Trial

— PROCOL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03624764
• Other study ID #: 2016- A01387-44
• Status: Completed
• Phase: N/A
• Start date: January 4, 2017
• Est. completion date: January 4, 2020

Study information

• Verified date: February 2021
• Source: Clinique Beau Soleil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 4, 2020
• Est. primary completion date: October 4, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prolapse

Intervention

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)
• 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

Locations

Country	Name	City	State
France	Clinique Beau Soleil	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Clinique Beau Soleil

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time	The time elapsed between incision and closure	one day
Secondary	Collection of intra-operative complications	Collection of all the complications during the surgery (visceral wound, peroperative bleeding, other)	one day
Secondary	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
Secondary	Collection of complications at 6 weeks	Pain by the Visuel Analog Scale, emergency consultation or generalist, rehospitalization / Reintervention, other complications	6 weeks
Secondary	Tolerance of the prosthesis	Classification of the complications related to the insertion of protheses (from the International Urogynecological Association)	6 weeks
Secondary	Tolerance of the prosthesis	Classification of the complications related to the insertion of protheses (from the International Urogynecological Association)	6 months
Secondary	Tolerance of the prosthesis	Classification of the complications related to the insertion of protheses (from the International Urogynecological Association)	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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