A Novel Approach to Posterior Mesh Fixation in Laparoscopic Sacral Colpopexy

Not Applicable

• Conditions: Pelvic Organ Prolapse
• Interventions: Procedure: laparoscopic sacral colpopexy with posterior mesh attachment; Procedure: laparoscopic sacral colpopexy with posterior mesh no attachment

• Registration Number: NCT04358978
• Lead Sponsor: Catholic University of the Sacred Heart

Brief Summary

This randomized controlled study is designed to test the non inferiority of no attachment of posterior mesh compared to fixation of posterior mesh to the vagina in laparoscopic sacral colpopexy in terms of anatomical correction of the prolapse, post-operative and long term morbidity and rate of recurrence.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-21
• Study First Submitted QC: 2020-04-21
• Study Start: 2020-04-23
• Study First Posted: 2020-04-24
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-22
• Last Update Posted: 2020-07-24
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

-patients who required surgical treatment for symptomatic pelvic organ prolapse stage ≥ 2 with or without stress urinary incontinence

Exclusion Criteria

• Age > 75 years
• Severe cardiovascular or respiratory disease
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
posterior mesh attachment	laparoscopic sacral colpopexy with posterior mesh attachment	laparoscopic sacral colpopexy with fixation of posterior mesh by suture
posterior mesh no attachment	laparoscopic sacral colpopexy with posterior mesh no attachment	laparoscopic sacral colpopexy with no fixation of posterior mesh

Primary Outcome Measures

Name	Time	Method
correction of pelvic organ prolapse	1 year	number of women with correction of prolapse mesured in S POP-Q stage during FU visit

Secondary Outcome Measures

Name	Time	Method
rate of recurrence	1 year	number of women with de novo anterior or posterior or central prolapse
long term outcomes	1 year	number of women with nicturia, dysuria, obstructed defecation , urinary incontinence, pelvic pain

Trial Locations

Locations (1)

ospedale regionale Miulli; 🇮🇹 Acquaviva delle Fonti, Bari, Italy