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Comparison of the Efficacy of Sacrocolpopexy, the Amreich-Richter Procedure and Transvaginal Mesh
Sponsor: Charles University, Czech Republic
Summary
Pelvic organ prolapse, POP, is a common health problem affecting up to 40% of women. Very little is known about the factors associated with surgical failure. Studies have identified a variety of risk factors: younger age, high body mass index and advanced preoperative prolapse (grade III-IV) have been associated with an increased risk of reoperation in some studies. According to some studies patients had poorer anatomical outcome after traditional repairs but were able to enjoy the same quality of life as after transvaginal mesh surgery or laparoscopic sacrocolpopexy. The purpose of this study is to assess and compare the efficacy of these three procedures in a randomized controlled trial.
Official title: Comparison of the Efficacy of Three Surgical Methods in the Treatment of POP: Sacrocolpopexy,the Amreich-Richter Procedure and Transvaginal Mesh
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
462
Start Date
2016-09-01
Completion Date
2028-03
Last Updated
2023-02-15
Healthy Volunteers
No
Conditions
Interventions
Laparoscopic sacrocolpopexy
see arm/group descriptions
Transvaginal mesh procedure
see arm/group descriptions
Amreich-Richter procedure
see arm/group descriptions
Locations (7)
Frýdek-Místek regional hospital
Frýdek-Místek, Czechia
Faculty of Medicine in Olomouc, Palackeho University
Olomouc, Czechia
Faculty of Medicine in Pilsen, Charles University
Pilsen, Czechia
General University Hospital, 1st Faculty of Medicine, Charles University
Prague, Czechia
Hospital Na Bulovce, 1st Faculty of Medicine, Charles University
Prague, Czechia
Tomas Bata Regional Hospital in Zlin
Zlín, Czechia
Louis Pasteur University Hospital Kosice
Košice, Slovakia