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ACTIVE NOT RECRUITING
NCT03053479
NA

Comparison of the Efficacy of Sacrocolpopexy, the Amreich-Richter Procedure and Transvaginal Mesh

Sponsor: Charles University, Czech Republic

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

Laparoscopic sacrocolpopexy

see arm/group descriptions

PROCEDURE

Transvaginal mesh procedure

see arm/group descriptions

PROCEDURE

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