Different Types of Suture for Sacral Colpopexy

Not Applicable

Completed

• Conditions: Pelvic Organ Prolapse
• Interventions: Procedure: laparoscopic sacral colpopexy with absorbable suture; Procedure: laparoscopic sacral colpopexy with non absorbable suture

• Registration Number: NCT03582410
• Lead Sponsor: Catholic University of the Sacred Heart

Brief Summary

This randomized controlled study is designed to test absorbable suture compared to non absorbable suture in laparoscopic sacral colpopexy in terms of anatomical correction of the prolapse, post-operative and long term morbidity, rate of recurrence, subjective satisfaction of the patient and rate of mesh erosion.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-06
• Study First Submitted QC: 2018-07-09
• Study Start: 2018-07-10
• Study First Posted: 2018-07-11
• Primary Completion: 2020-02-10
• Study Completion: 2020-02-10
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-28
• Last Update Posted: 2020-03-31

Recruitment & Eligibility

• Status: COMPLETED
• 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
Absorbable suture	laparoscopic sacral colpopexy with absorbable suture	laparoscopic sacral colpopexy with absorbable suture
Non absorbable suture	laparoscopic sacral colpopexy with non absorbable suture	laparoscopic sacral colpopexy with non absorbable suture

Primary Outcome Measures

Name	Time	Method
Number of patients with anatomical correction of the prolapse	1 year	Anatomical correction of the prolapse evaluated by gynecological visit

Secondary Outcome Measures

Name	Time	Method
long term outcomes	1 year	development of nicturia, dysuria, obstructed defecation , urinary incontinence
rate mesh erosion	1 year
Rate of recurrence	1 year	de novo anterior or central or posterior compartment prolapse

Trial Locations

Locations (1)

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