Vaginal Native Tissues Repair for Pelvic Organ Prolapse

Обзор

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.

Подробное описание

Pelvic organ prolapse is usually the result of loss of pelvic support. It is widely accepted that 50% of women after 50 years old will develop prolapse, evaluated through the POPQ Classification . Pelvic organ prolapse cause significant psychological distress and negatively affect quality of life. Among the surgery for prolapse, the cystocele cureis is the most frequent (67.7%). Native tissue cystocele repairs is the cornerstone of prolapse surgery especially since the learned societies (Food and Drug Administration, Haute Autorité de Santé, Collège National des Gynécologues-Obstétriciens Français) warned clinicians and patients about serious mesh related complications. In France, 41.5% of vaginal cystocele repair are with native tissue. The main surgeries are anterior colporraphy and vaginal patch plastron, used in routine in our center with re-intervention rates less than 4% at one year. Rate of success of native tissue cystocele repair are heterogeneous, depending on the design of studies and definition of outcomes. A prospective study find a success rate at 35% of the anterior colporraphy based on a combined definition, anatomic and functional as recommended recently. However the definition of anatomic was strict (POPQ\<2), while it seems that the best definition of anatomic success is "no prolapse among the hymen", that is to say aAa and Ba points \<0.

We think that the vaginal patch plastron will have a better anatomic and functional success comparatively to the anterior colporraphy as it corrects median cystoceles by a vaginal strip as well as lateral cystoceles by the bilateral paravaginal suspension.

The description of the two surgeries will be standardized between all the surgeons. We will compare the anterior colporraphy consisting in bladder median support by retensioning Halban fascia with colpectomy to the vaginal patch plastron consisting in making a vaginal strip attached to the bladder combined with suspension by fixation of the vaginal strip to the tendinous arch of the pelvic fascia.

Patients will be blind of their surgery. They will have a follow-up visit 45 days after the surgery to evaluate the post- operative complications according to the Clavien-Dindo classification. They will have phone call at 4 and 8 months after the surgery to make sure they've not suffered for complications. At last, they will have a follow-up visit 1 year after the surgery by an independent assessor blind of the surgery to evaluate the primary outcome (anatomic and functional success).

Вмешательства

• Процедура 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 c
• Процедура 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.

Первичные конечные точки

• Rate of the prolapse surgery [Срок оценки: 1 year]

Вторичные конечные точки (5)

• Rate of the prolapse surgery [Срок оценки: 1 year]
• Rate of post-operative complications [Срок оценки: 45 Days]
• Sexual function [Срок оценки: 1 year]
• Rate of the prolapse surgery [Срок оценки: 2 years]
• Rate of the prolapse surgery [Срок оценки: 3 years]

Критерии участия

Критерии включения

• Patient at 50 years of age or older
• Symptomatic primary prolapse of the anterior vaginal wall defined by Aa and/or Ba points ≥0 according to the POP-Q system
• A positive response to the question "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?" (question 3 of the PFDI-20)
• Able to give informed consent
• Performans Status score ≤ 2

Критерии исключения

• Patient with need for surgical treatment for myorraphy of levator ani muscles
• Patient with previous surgical cystocele repair.
• Patient with evolving gynaecologic cancer.
• Pregnancy or wish for future pregnancy, lactating woman.
• Inability to participate in study follow-up or to provide informed consent.
• Lack of social insurance .

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Франция · 9 центров

• CHU de Bordeaux — Bordeaux
• CH de Brive — Brive-la-Gaillarde
• CHU de Clermont Ferrand — Clermont-Ferrand
• CH de Gueret — Guéret
• CHU de Limoges — Limoges
• CHU de Saint-Etienne — Saint-Etienne
• CHU de Toulouse - Paule de Viguier — Toulouse
• CHU de Toulouse - Rangueil — Toulouse
• … и ещё 1 центр

Публикации

• Lacorre A, Vidal F, Campagne-Loiseau S, Marin B, Aubard Y, Siegerth F, Mesnard C, Chantalat E, Hocke C, Gauthier T. Protocol for a randomized controlled trial to assess two procedures of vaginal native tissue repair for pelvic organ prolapse at the time of the questioning on vaginal prosthesis: the TAPP trial. Trials. 2020 Jul 8;21(1):624. doi: 10.1186/s13063-020-04512-x. PMID 32641096

Идентификаторы

NCT: NCT03875989 · 87RI18_0013 (TAPP)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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