Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT03875989 En recrutement

Titre

Vaginal Native Tissues Repair for Pelvic Organ Prolapse (TAPP)

Type

Interventional

Pathologie

Prolapsus
Prolapsus utérin
Prolapsus d'organe pelvien

Phase

N/A

Promoteur

University Hospital, Limoges (Voir sur ClinicalTrials)

Date de début

septembre 2019

Date de fin

mars 2028

Dernière mise à jour

29 juin 2024

Résumé

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.

Détail

Voir le détail 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). Fermer le détail

Etablissements

Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CH de Brive - 19100 - Brive-la-Gaillarde - France	Christelle MESNARD, MD	En recrutement	Contact (sur clinicalTrials)
CH de Gueret - 23000 - Guéret - France	Yves AUBARD, MD	En recrutement	Contact (sur clinicalTrials)
CH de Tulle - 19000 - Tulle - France	François SIEGERTH, MD	En recrutement	Contact (sur clinicalTrials)
CHU de Clermont Ferrand - 63100 - Clermont-Ferrand - France	Sandrine CAMPAGNE, MD	En recrutement	Contact (sur clinicalTrials)
CHU de Limoges - 87000 - Limoges - France	Aymeline LACORRE, MD	En recrutement	Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHU de Bordeaux - 33000 - Bordeaux - France	Claude HOCKE, MD	En recrutement	Contact (sur clinicalTrials)
CHU de Saint-Etienne - 42000 - Saint-Étienne - France	Céline CHAULEUR, MD	En recrutement	Contact (sur clinicalTrials)
CHU de Toulouse - Paule de Viguier - 31059 - Toulouse - France	Hélène POL, MD	En recrutement	Contact (sur clinicalTrials)
CHU de Toulouse - Rangueil - 31400 - Toulouse - France	Elodie CHANTALAT, MD	En recrutement	Contact (sur clinicalTrials)

Critères

Genre

Femme

Nombre d'inclusion

Critère d'inclusion

Inclusion Criteria:

- 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

Critère de non inclusion

- 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 .

NCT03875989 - Vaginal Native Tissues Repair for Pelvic Organ Prolapse (TAPP)

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Etablissements
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