Laparoscopic Fascial Duplication Plus Sacral Colpopexy in Posterior Vaginal Prolapse

Not Applicable

Completed

• Conditions: Pelvic Organ Prolapse; Posterior Vaginal Wall Prolapse
• Interventions: Procedure: Laparoscopic Fascial Posterior Vagina Duplication

• Registration Number: NCT05252637
• Lead Sponsor: Azienda Ospedaliera Cardinale G. Panico

Brief Summary

A Randomized Clinical Trial on Laparoscopic Fascial posterior vaginal duplication with absorbable sutures plus sacral colpopexy mesh placement VS sacral colpopexy isolated for vaginal posterior prolapse

Detailed Description

Laparoscopic sacral colpopexy is the gold standard procedure for pelvic organ prolapse. Anyway, vaginal fascial surgery is already considered the most appropriate for posterior vaginal prolapse. This prospective randomized pilot study is aimed to verify if the combination of laparoscopic duplication of vaginal fascia with absorbable sutures could increase benefits of sacral colpopexy on the posterior vagina in terms of prolapse (evaluating 1 year POP-Q).

Secondary endpoints of this comparison are incidence of intra- or postoperative complications estimated blood loss, postoperative pain (evaluated by VAS), days of hospitalization and costs for the health care system.

Statistical Analysis and Study Design This is a single Institution prospective randomized clinical trial conducted at the Pia Fondazione Panico of Tricase, Italy.

To have an imbalanced results and to reduce any bias, a randomization list has been checked.

Probability (p) values will be considered to be statistically significant at the \<0.05 level.

There will be recruited 32 patients for Groups. Group 1: Laparoscopic Fascial posterior vaginal duplication with absorbable sutures plus sacral colpopexy mesh placement Vs Group 2: Laparoscopic sacral colpopexy isolated for vaginal posterior prolapse.

All patients will be adequately informed and inserted in the study only after having read and signed an informed consent. Diagnostic, clinical and surgical data of each patient will be prospectively recorded. At the end of the procedure, a schedule will be compiled with intraoperative data. All clinical and histologic data will be recorded prospectively using a database. Pain associated with the procedure will be evaluated by a subjective assessment (analysis of VAS scale values reported by patients at 8 and 24 hours after surgery). Post-operative complications will be evaluated during the first 30 days after surgery according to Dindo's classification.

Study Timeline

• Study Start: 2019-11-01
• Primary Completion: 2021-01-20
• Study Completion: 2022-01-20
• Status Verified: 2022-02
• Study First Submitted: 2022-02-13
• Study First Submitted QC: 2022-02-13
• Last Update Submitted: 2022-02-13
• Study First Posted: 2022-02-23
• Last Update Posted: 2022-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 64

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Duplication plus LSC	Laparoscopic Fascial Posterior Vagina Duplication	Laparoscopic duplication of posterior vagina plus mesh placement

Primary Outcome Measures

Name	Time	Method
POP-Q	1 year	POP-Q evaluation

Trial Locations

Locations (1)

Pia Fondazione Panico; 🇮🇹 Tricase, Lecce, Italy