Different Types of Suture for Sacral Colpopexy

Catholic University of the Sacred Heart

Status: Completed

Conditions: Pelvic Organ Prolapse

Treatments: Procedure: laparoscopic sacral colpopexy with non absorbable suture; Procedure: laparoscopic sacral colpopexy with absorbable suture

Study type: Interventional

Funder types: Other

Identifiers

NCT03582410

ospedale regionale F. Miulli

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: Female

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Absorbable suture

Active Comparator group

Description:

laparoscopic sacral colpopexy with absorbable suture

Treatment:

Procedure: laparoscopic sacral colpopexy with absorbable suture

Non absorbable suture

Active Comparator group

Description:

laparoscopic sacral colpopexy with non absorbable suture

Treatment:

Procedure: laparoscopic sacral colpopexy with non absorbable suture