RecruitingNot ApplicableNCT03875989

Vaginal Native Tissues Repair for Pelvic Organ Prolapse


Sponsor

University Hospital, Limoges

Enrollment

214 participants

Start Date

Sep 27, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Anterior colporraphy and a procedure called vaginal patch plastron for people with prolapse, vaginal. The study is currently recruiting participants at 9 locations. People eligible for this study include women aged 50 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAnterior 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.

PROCEDUREvaginal 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

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NCT03875989


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