Different Types of Suture for Sacral Colpopexy

Absorbable vs Non-absorbable Suture in Laparoscopic Sacral Colpopexy: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Procedure: laparoscopic sacral colpopexy with absorbable suture; Procedure: laparoscopic sacral colpopexy with non absorbable suture

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bari
    • Acquaviva delle Fonti, Bari, Italy, 70021
      • ospedale regionale Miulli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Absorbable suture; laparoscopic sacral colpopexy with absorbable suture	Procedure: laparoscopic sacral colpopexy with absorbable suture; laparoscopic sacral colpopexy to correct pelvic organ prolapse with anterior and posterior meshes with absorbable suture
Active Comparator: Non absorbable suture; laparoscopic sacral colpopexy with non absorbable suture	Procedure: laparoscopic sacral colpopexy with non absorbable suture; laparoscopic sacral colpopexy to correct pelvic organ prolapse with anterior and posterior meshes with non absorbable suture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with anatomical correction of the prolapse	Anatomical correction of the prolapse evaluated by gynecological visit	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Catholic University of the Sacred Heart
• Collaborators: Miulli General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2018
• Primary Completion (Actual): February 10, 2020
• Study Completion (Actual): February 10, 2020

Study Registration Dates

• First Submitted: June 6, 2018
• First Submitted That Met QC Criteria: July 9, 2018
• First Posted (Actual): July 11, 2018

Study Record Updates

• Last Update Posted (Actual): March 31, 2020
• Last Update Submitted That Met QC Criteria: March 28, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: ospedale regionale F. Miulli

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No