Laparoscopic Sacrocolpexy Versus Lateral Suspension

Study Overview
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Brief Summary
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Surgical treatment of genital prolapse can be performed by laparoscopic surgery or by vaginal surgery, with or without using meshes. Laparoscopic sacrocolpopexy, which consist in fixing a mesh between vaginal anterior wall and the promontory is the gold standard procedure to treat anterior prolapse or of the vaginal vault. Most of studies shows a success rate of 80% of this procedure. However, access to the promontory could be difficult in patients because of adherences or anatomical reasons. This step of the procedure also exposes to risk of ureteral or vascular injuries. Recent issues have also found spondylodiscitis cases. The technique of laparoscopic lateral suspension with mesh was developed by Dubuisson in 1998 allows not to have to approach the promontory and avoids both the risk of vascular injury and ureteral damage of laparoscopic sacrocolpopexy. Instead of attach the mesh to the promontory, the procedure consists in spreading out bilaterally, a subperitoneal T-shaped mesh in the anterior abdominal wall. The aim of this study is to compare the clinical and functional efficiency of the lateral suspension versus laparoscopic sacrocolpopexy. It is a prospective, randomized, monocentric study compared two groups The study hypothesis is that the lateral suspension would provide correction than the laparoscopic sacrocolpopexy. The primary outcome is the comparison of anatomic correction rates at 1 year Success is defined as 1 year Ba et C points < -1 centimeter in POP-Q international score. Secondary endpoints are improve of quality of life evaluated with the validated P-QOL questionnaire, and complications rates, including post-operative posterior prolapse. Number of subjects required is 72 patients, 36 in each group having a laparoscopic sacrocolpopexy or lateral suspension. Outcomes will be evaluated at 1 month and 1 year post-operative consultation

Official Title
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Laparoscopic Sacrocolpexy Versus Lateral Suspension With a Mesh for the Treatment of Pelvic Organ Prolapse : a Randomized Controlled Trial

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Procedure: Surgical treatment of genital prolapse


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients at least 18 years old. Patients who agreed to participate in the study and signed informed consent. Patient affiliated to a social protection system. Surgical indication by laparoscopy of prolapse cure symptomatic of the anterior stage and / or isolated medium. Exclusion Criteria: Minor patient. Patient refusing to sign the consent or unable to receive the necessary information to give informed consent. Patient not affiliated to a social protection system. Presence of one or more contraindication (s) to laparoscopy Presence of posterior prolapse requiring surgical treatment Need for an associated surgical procedure. Major people under legal protection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: promontory<br>Laparoscopic sacrocolpopexy, which consist in fixing a mesh between vaginal anterior wall | Procedure: Surgical treatment of genital prolapse<br>* Laparoscopy performed according to the usual technique of the participating center with pneumoperitoneum between 12 and 15 mmHg. Placement of the 5 mm trocar operator left and right iliac fossa and 5 mm pubic addition.<br>|
| Active Comparator: laparoscopic lateral suspension<br>The procedure consists in spreading out bilaterally, a subperitoneal T-shaped mesh in the anterior abdominal wall | Procedure: Surgical treatment of genital prolapse<br>* Laparoscopy performed according to the usual technique of the participating center with pneumoperitoneum between 12 and 15 mmHg. Placement of the 5 mm trocar operator left and right iliac fossa and 5 mm pubic addition.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate cervico-urethral hypermobility | Success is defined by two points inferior at 1 centimeter in Pelvic organs prolapse quantification (POP-Q) international score. defining a symptomatic or asymptomatic state | one year |