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Laparoscopic Sacrocolpopexy Versus POPS in the Management of Pelvic Prolapse

NCT ID: NCT02911584

Last Updated: 2017-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pelvic Organ Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Sacral colpopexy

Laparoscopic procedure

Group Type ACTIVE_COMPARATOR

Laparoscopic procedure

Intervention Type PROCEDURE

POPS

Laparoscopic procedure: Pelvic Organs Prolapse Suspension

Group Type ACTIVE_COMPARATOR

Laparoscopic procedure

Intervention Type PROCEDURE

Interventions

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Laparoscopic procedure

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Miulli General Hospital

OTHER

Sponsor Role collaborator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Valeria Tagliaferri

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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CSP1

Identifier Type: -

Identifier Source: org_study_id