Laparoscopic Sacrocolpopexy Versus POPS in the Management of Pelvic Prolapse
December 4, 2017 updated by: Valeria Tagliaferri, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Laparoscopic Sacrocolpopexy Versus POPS in the Surgical Management of Pelvic Organ Prolapse: A Prospective Randomized Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Sacral colpopexy
Laparoscopic procedure
|
|
|
Active Comparator: POPS
Laparoscopic procedure: Pelvic Organs Prolapse Suspension
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of patients with anatomical correction of the prolapse
Time Frame: up to 6 months
|
Anatomical correction of the prolapse evaluated by gynecological visit
|
up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of recurrence
Time Frame: up to 6 months
|
up to 6 months
|
|
|
Post operative quality of life
Time Frame: up to 6 months
|
Subjective satisfaction of the patient evaluated by a quality of life questionnaire.
|
up to 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2016
Primary Completion (Actual)
May 1, 2017
Study Completion (Actual)
September 1, 2017
Study Registration Dates
First Submitted
September 15, 2016
First Submitted That Met QC Criteria
September 21, 2016
First Posted (Estimate)
September 22, 2016
Study Record Updates
Last Update Posted (Actual)
December 6, 2017
Last Update Submitted That Met QC Criteria
December 4, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSP1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.