Different Types of Suture for Sacral Colpopexy

• Sponsor: Catholic University of the Sacred Heart (Other)
• Overall Status: Completed
• CT.gov ID: NCT03582410
• Collaborator: Miulli General Hospital (Other)
• Enrollment: 150
• Location: 1
• Arms: 2
• Actual Duration (Months): 19.1
• Patients Per Site Per Month: 7.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse	Procedure: laparoscopic sacral colpopexy with absorbable suture; Procedure: laparoscopic sacral colpopexy with non absorbable suture	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Absorbable vs Non-absorbable Suture in Laparoscopic Sacral Colpopexy: a Randomized Controlled Trial
• Actual Study Start Date: Jul 10, 2018
• Actual Primary Completion Date: Feb 10, 2020
• Actual Study Completion Date: Feb 10, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of patients with anatomical correction of the prolapse [1 year]

   Anatomical correction of the prolapse evaluated by gynecological visit

Secondary Outcome Measures

1. rate mesh erosion [1 year]

2. long term outcomes [1 year]

   development of nicturia, dysuria, obstructed defecation , urinary incontinence

3. Rate of recurrence [1 year]

   de novo anterior or central or posterior compartment prolapse

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 75 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ospedale regionale Miulli	Acquaviva delle Fonti	Bari	Italy	70021

Sponsors and Collaborators

• Catholic University of the Sacred Heart
• Miulli General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maurizio Guido, Clinical Professor, Catholic University of the Sacred Heart
• ClinicalTrials.gov Identifier: NCT03582410
• Other Study ID Numbers: ospedale regionale F. Miulli
• First Posted: Jul 11, 2018
• Last Update Posted: Mar 31, 2020
• Last Verified: Mar 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prolapse; Pelvic Organ Prolapse

Study Results

No Results Posted as of Mar 31, 2020