NCT02911584
Completed
Not Applicable
Laparoscopic Sacrocolpopexy Versus POPS in the Surgical Management of Pelvic Organ Prolapse: A Prospective Randomized Trial
ConditionsPelvic Organ Prolapse
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pelvic Organ Prolapse
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Enrollment
- 30
- Primary Endpoint
- Number of patients with anatomical correction of the prolapse
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief 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.
Investigators
Valeria Tagliaferri
Medical Doctor
Miulli General Hospital
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 \> 70 years
- •Severe cardiovascular or respiratory disease
- •Pregnancy
- •Previous surgical procedure for POP correction
Outcomes
Primary Outcomes
Number of patients with anatomical correction of the prolapse
Time Frame: up to 6 months
Anatomical correction of the prolapse evaluated by gynecological visit
Secondary Outcomes
- Post operative quality of life(up to 6 months)
- Rate of recurrence(up to 6 months)
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