Status:
NOT_YET_RECRUITING
Sacrocolpopexy Versus Sacro-spinous Fixation for Prolapse Treatment
Lead Sponsor:
Centre Hospitalier Universitaire Vaudois
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
30+ years
Phase:
NA
Brief Summary
Prolapse is a condition that causes up to 13% of women to have surgery in their lifetime. There are many surgical techniques for the treatment of prolapse, each with its advantages and disadvantages. ...
Detailed Description
Genital prolapse is caused by the collapse of the supporting structures of the pelvic organs. This results in the organs sliding down through the pelvic hiatus. The pelvic organs involved are the blad...
Eligibility Criteria
Inclusion
- Patients who:
- Have symptomatic prolapse, degree ≥ 2
- Want surgical management
- Accept subtotal hysterectomy
- Accept the idea of being in the arm of the study, which involves the placement of prosthetic material
- After explaining and reading the information sheet, have understood and signed the consent form
Exclusion
- Refuse hysterectomy
- Refuse the idea of having prosthetic material implanted
- Prefer conservative management
- Have insufficient understanding of French
- Still wish a pregnancy
- Are not in a condition to withstand surgery of this type
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT04878146
Start Date
July 1 2021
End Date
June 30 2028
Last Update
May 7 2021
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