A Randomized Comparative Study of Assisted Promontofixation Using Glue Versus Promontofixation Using Threads
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Clinique Beau Soleil
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Operative time
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age> 40 years
- •Surgical indication of prolapse cure by promontofixation
- •Valid social insurance
- •French spoken and written
- •Informed consent signed
Exclusion Criteria
- •Exclusion Criteria:
- •Concomitant rectopexy
- •Concomitant Hysterectomy
- •Associated surgical procedure not compatible with measurement of operative time
- •Refusal to participate in the study
- •Pregnant or lactating woman (Article L 1121-5 of the french code of public health)
- •Vulnerable persons (Article L 1121-6 of the french code of public health)
- •Majors subject to legal protection or unable to express their consent (Article 1121-8 of the CSP)
- •Participation in another protocol for less than 3 months
- •Patient does not have all the inclusion criteria.
Arms & Interventions
Promontofixation using glue
Patients in this arm will have a laparoscopic promontofixation using a biocompatible cyanoacrylate adhesive replacing some sutures to maintain the strips.
Intervention: Laparostopic promontofixation using surgical glue (Procedure)
Promontofixation using threads
Patients in this arm will have a laparoscopic promontofixation using sutures with threads to maintain the strips.
Intervention: Laparostopic promontofixation using threads (Procedure)
Outcomes
Primary Outcomes
Operative time
Time Frame: one day
The time elapsed between incision and closure
Secondary Outcomes
- Collection of complications at 6 weeks(6 weeks)
- Collection of intra-operative complications(one day)
- Collection of per-operative complications(one day)
- Tolerance of the prosthesis(12 months)
- Objective anatomical results at 6 weeks(Before surgery)
- Objective anatomical results at 6 months(6 months after surgery)
- Objective anatomical results at 12 month(12 months after surgery)
- Quality of life: pelvic floor distress(12 months after the surgery)
- Tolerance of the prosthesis(6 weeks)
- Tolerance of the prosthesis(6 months)
- Quality of life: pelvic floor distress(Before the surgery)
- Quality of life: pelvic floor distress(6 months after the surgery)