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RECRUITING
NCT03875989
NA

Vaginal Native Tissues Repair for Pelvic Organ Prolapse

Sponsor: University Hospital, Limoges

View on ClinicalTrials.gov

Summary

The aim of the study is to assess at one year the effectiveness of the vaginal patch plastron in comparison of the anterior colporraphy through a combined definition of success: anatomic and functional.

Key Details

Gender

FEMALE

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

214

Start Date

2019-09-27

Completion Date

2028-03-27

Last Updated

2023-08-29

Healthy Volunteers

No

Interventions

PROCEDURE

Anterior colporraphy

It will be delimitate a rectangular vaginal strip which will be isolated from the anterior colpocele. The superior edge of the strip is placed 2 cm from the urethral orifice. After lateral vesico-vaginal dissection, the paravesical fossae will be wide opened to repair the tendinous arches. The vaginal plastron will be fixed to the tendinous arch of the pelvic fascia by 3 lateral stitches (anterior/ lateral/ posterior) on each side of the plastron. After, the plastron will be tensioning and the cystocele will be suspended. The closure of the vaginal wall will end the procedure.

PROCEDURE

vaginal patch plastron

It will be make a midline incision of the anterior vaginal wall from the urethrovesical junction to the vaginal apex or anterior fornix. The vaginal epithelium will be separated from the underlying fibromuscular layer (Halban Fascia) after the midline incision. Midline plication of the fibromuscular layer will be obtained by interrupted horizontal stiches. The closure of the vaginal wall will end the procedure.

Locations (9)

CHU de Bordeaux

Bordeaux, France

CH de Brive

Brive-la-Gaillarde, France

CHU de Clermont Ferrand

Clermont-Ferrand, France

CH de Gueret

Guéret, France

CHU de Limoges

Limoges, France

CHU de Saint-Etienne

Saint-Etienne, France

CHU de Toulouse - Paule de Viguier

Toulouse, France

CHU de Toulouse - Rangueil

Toulouse, France

CH de Tulle

Tulle, France