Status:
UNKNOWN
A Novel Approach to Posterior Mesh Fixation in Laparoscopic Sacral Colpopexy
Lead Sponsor:
Catholic University of the Sacred Heart
Collaborating Sponsors:
Miulli General Hospital
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
Up to 75 years
Phase:
NA
Brief Summary
This randomized controlled study is designed to test the non inferiority of no attachment of posterior mesh compared to fixation of posterior mesh to the vagina in laparoscopic sacral colpopexy in ter...
Eligibility Criteria
Inclusion
- patients who required surgical treatment for symptomatic pelvic organ prolapse stage ≥ 2 with or without stress urinary incontinence
Exclusion
- Age \> 75 years
- Severe cardiovascular or respiratory disease
- Pregnancy
Key Trial Info
Start Date :
April 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2021
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04358978
Start Date
April 23 2020
End Date
September 30 2021
Last Update
July 24 2020
Active Locations (1)
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1
ospedale regionale Miulli
Acquaviva delle Fonti, Bari, Italy, 70021