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NCT03582410 Clinical Trial

Different Types of Suture for Sacral Colpopexy

Pelvic Organ Prolapse Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03582410
Other study ID # ospedale regionale F. Miulli
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 10, 2018
Est. completion date February 10, 2020

Study information
Verified date March 2020
Source Catholic University of the Sacred Heart
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date February 10, 2020
Est. primary completion date February 10, 2020
Accepts healthy volunteers No
Gender Female
Age group 40 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• laparoscopic sacral colpopexy with absorbable suture
laparoscopic sacral colpopexy to correct pelvic organ prolapse with anterior and posterior meshes with absorbable suture
• laparoscopic sacral colpopexy with non absorbable suture
laparoscopic sacral colpopexy to correct pelvic organ prolapse with anterior and posterior meshes with non absorbable suture

Locations
Country Name City State
Italy ospedale regionale Miulli Acquaviva delle Fonti Bari

Sponsors (2)
Lead Sponsor Collaborator
Catholic University of the Sacred Heart Miulli General Hospital

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients with anatomical correction of the prolapse Anatomical correction of the prolapse evaluated by gynecological visit 1 year
Secondary rate mesh erosion 1 year
Secondary long term outcomes development of nicturia, dysuria, obstructed defecation , urinary incontinence 1 year
Secondary Rate of recurrence de novo anterior or central or posterior compartment prolapse 1 year
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