Clinical trial NCT03624764: Assisted Promontofixation Using Glue Versus Promontofixation Using Threads (PROCOL)
Official title: A Randomized Comparative Study of Assisted Promontofixation Using Glue Versus Promontofixation Using Threads
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prolapse
Keywords: promontofixation
prolapse surgery
Lead sponsor: Clinique Beau Soleil
Sponsor class: OTHER
First posted: 2018-08-10
Enrollment: 90
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Operative time
timeFrame: one day
Secondary outcomes:
measure: Collection of intra-operative complications
timeFrame: one day
measure: Collection of per-operative complications
timeFrame: one day
measure: Collection of complications at 6 weeks
timeFrame: 6 weeks
measure: Tolerance of the prosthesis
timeFrame: 6 weeks
measure: Tolerance of the prosthesis
timeFrame: 6 months
measure: Tolerance of the prosthesis
timeFrame: 12 months
measure: Objective anatomical results at 6 weeks
timeFrame: Before surgery
measure: Objective anatomical results at 6 months
timeFrame: 6 months after surgery
measure: Objective anatomical results at 12 month
timeFrame: 12 months after surgery
measure: Quality of life: pelvic floor distress
timeFrame: Before the surgery
measure: Quality of life: pelvic floor distress
timeFrame: 6 months after the surgery
measure: Quality of life: pelvic floor distress
timeFrame: 12 months after the surgery
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Clinique Beau Soleil
Study officials:
affiliation: Clinqieu Beau Soleil
name: Christophe Courtieu
role: PRINCIPAL_INVESTIGATOR
References: