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Different Types of Suture for Sacral Colpopexy

Primary Purpose

Pelvic Organ Prolapse

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
laparoscopic sacral colpopexy with absorbable suture
laparoscopic sacral colpopexy with non absorbable suture
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • ospedale regionale Miulli

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Absorbable suture

Non absorbable suture

Arm Description

laparoscopic sacral colpopexy with absorbable suture

laparoscopic sacral colpopexy with non absorbable suture

Outcomes

Primary Outcome Measures

Number of patients with anatomical correction of the prolapse
Anatomical correction of the prolapse evaluated by gynecological visit

Secondary Outcome Measures

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

Full Information

First Posted
June 6, 2018
Last Updated
March 28, 2020
Sponsor
Catholic University of the Sacred Heart
Collaborators
Miulli General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03582410
Brief Title
Different Types of Suture for Sacral Colpopexy
Official Title
Absorbable vs Non-absorbable Suture in Laparoscopic Sacral Colpopexy: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
July 10, 2018 (Actual)
Primary Completion Date
February 10, 2020 (Actual)
Study Completion Date
February 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart
Collaborators
Miulli General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Absorbable suture
Arm Type
Active Comparator
Arm Description
laparoscopic sacral colpopexy with absorbable suture
Arm Title
Non absorbable suture
Arm Type
Active Comparator
Arm Description
laparoscopic sacral colpopexy with non absorbable suture
Intervention Type
Procedure
Intervention Name(s)
laparoscopic sacral colpopexy with absorbable suture
Intervention Description
laparoscopic sacral colpopexy to correct pelvic organ prolapse with anterior and posterior meshes with absorbable suture
Intervention Type
Procedure
Intervention Name(s)
laparoscopic sacral colpopexy with non absorbable suture
Intervention Description
laparoscopic sacral colpopexy to correct pelvic organ prolapse with anterior and posterior meshes with non absorbable suture
Primary Outcome Measure Information:
Title
Number of patients with anatomical correction of the prolapse
Description
Anatomical correction of the prolapse evaluated by gynecological visit
Time Frame
1 year
Secondary Outcome Measure Information:
Title
rate mesh erosion
Time Frame
1 year
Title
long term outcomes
Description
development of nicturia, dysuria, obstructed defecation , urinary incontinence
Time Frame
1 year
Title
Rate of recurrence
Description
de novo anterior or central or posterior compartment prolapse
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
ospedale regionale Miulli
City
Acquaviva delle Fonti
State/Province
Bari
ZIP/Postal Code
70021
Country
Italy

12. IPD Sharing Statement

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Different Types of Suture for Sacral Colpopexy

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