SUSPENSION: Laparoscopic Sacrocolpexy Versus Lateral Suspension

• Sponsor: Assistance Publique Hopitaux De Marseille (Other)
• Overall Status: Completed
• CT.gov ID: NCT03582852
• Collaborator: (none)
• Enrollment: 7
• Location: 1
• Arms: 2
• Actual Duration (Months): 36.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse	Procedure: Surgical treatment of genital prolapse	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Laparoscopic Sacrocolpexy Versus Lateral Suspension With a Mesh for the Treatment of Pelvic Organ Prolapse : a Randomized Controlled Trial
• Actual Study Start Date: Apr 11, 2018
• Actual Primary Completion Date: Apr 20, 2021
• Actual Study Completion Date: Apr 20, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: promontory Laparoscopic sacrocolpopexy, which consist in fixing a mesh between vaginal anterior wall	Procedure: Surgical treatment of genital prolapse; 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.
Active Comparator: laparoscopic lateral suspension The procedure consists in spreading out bilaterally, a subperitoneal T-shaped mesh in the anterior abdominal wall	Procedure: Surgical treatment of genital prolapse; 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.

Outcome Measures

Primary Outcome Measures

1. Evaluate cervico-urethral hypermobility [one year]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assistance Publique Hôpitaux de Marseille	Marseille		France	13354

Sponsors and Collaborators

• Assistance Publique Hopitaux De Marseille

Investigators

• Study Director: Jean-Olivier ARNAUD, Director, Assistance Publique Hôpitaux de Marseille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique Hopitaux De Marseille
• ClinicalTrials.gov Identifier: NCT03582852
• Other Study ID Numbers: 2017-43; 2017-A02650-53
• First Posted: Jul 11, 2018
• Last Update Posted: Aug 9, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prolapse; Pelvic Organ Prolapse

Study Results

No Results Posted as of Aug 9, 2022