Laparoscopic Sacrocolpexy Versus Lateral Suspension

NCT03582852 | Completed

• 2 other identifiers: 2017-432017-A02650-53
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

promontory

ACTIVE COMPARATOR

Laparoscopic sacrocolpopexy, which consist in fixing a mesh between vaginal anterior wall

Procedure: Surgical treatment of genital prolapse

laparoscopic lateral suspension

ACTIVE COMPARATOR

The procedure consists in spreading out bilaterally, a subperitoneal T-shaped mesh in the anterior abdominal wall

Procedure: Surgical treatment of genital prolapse

Interventions

Surgical treatment of genital prolapse PROCEDURE

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.

laparoscopic lateral suspension; promontory

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-Olivier ARNAUD, Director

  Assistance Publique Hôpitaux de Marseille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: July 11, 2018
• Study Start: April 11, 2018
• Primary Completion: April 20, 2021
• Study Completion: April 20, 2021
• Last Updated: August 9, 2022

Record last verified: 2022-08

Locations

FR (1)