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NCT02911584 Clinical Trial

Laparoscopic Sacrocolpopexy Versus POPS in the Management of Pelvic Prolapse

Pelvic Organ Prolapse Clinical Trial

Official title:
Laparoscopic Sacrocolpopexy Versus POPS in the Surgical Management of Pelvic Organ Prolapse: A Prospective Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02911584
Other study ID # CSP1
Secondary ID
Status Completed
Phase N/A
First received September 15, 2016
Last updated December 4, 2017
Start date October 2016
Est. completion date September 2017

Study information
Verified date November 2017
Source Policlinico Universitario Agostino Gemelli
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is the first study comparing the laparoscopic sacropexy with Pelvic Organs Prolapse Suspension (POPS) to treat pelvic organ prolapse. This prospective randomized surgical trial is designed to test the clinical and functional effects of the two different laparoscopic procedures in terms of anatomical correction of the prolapse, post-operative and long term morbidity, rate of recurrence and subjective satisfaction of the patient evaluated by a quality of life questionnaire.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date September 2017
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender Female
Age group 30 Years to 70 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 > 70 years

- Severe cardiovascular or respiratory disease

- Pregnancy

- Previous surgical procedure for POP correction

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Laparoscopic procedure

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Policlinico Universitario Agostino Gemelli Miulli General Hospital

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 up to 6 months
Secondary Rate of recurrence up to 6 months
Secondary Post operative quality of life Subjective satisfaction of the patient evaluated by a quality of life questionnaire. up to 6 months
See also
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Recruiting NCT03146195 - The 3D Reconstruction Research of Pelvic Organ Prolapse Disease N/A
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Completed NCT02383199 - Polypropylene Mesh in Prolapse Surgery N/A
Terminated NCT01673360 - Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices N/A
Completed NCT01842464 - Sacro-Spinous Ligaments Anterior Apical Anchoring N/A
Withdrawn NCT01530191 - Factors Affecting Perioperative Outcomes N/A
Completed NCT01320631 - Male Sexual Experience and Its Impact on Quality of Life Before and After Their Sexual Partners Undergo Polypropylene Mesh Augmented Pelvic Floor Reconstruction N/A
Completed NCT00581412 - Composite Graft Use in Abdominal Sacrocolpopexy Reduces Erosion Rates N/A