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临床试验/NCT03875989
NCT03875989招募中不适用

Vaginal Native Tissues Repair for Pelvic Organ Prolapse

University Hospital, Limoges18 个研究点 分布在 1 个国家目标入组 214 人开始时间: 2019年9月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
214
试验地点
18
主要终点
Rate of the prolapse surgery

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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 .

结局指标

主要结局

Rate of the prolapse surgery

时间窗: 1 year

The success rate of the prolapse surgery defined by a composite of objective and subjective measures: * Anatomic success defined by Aa and Ba values \<0 in Pelvic Organ Prolapse Quantification System (POP-Q) AND * Subjective success through reliable condition-specific quality-of-life questionnaires: * A negative 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 Pelvic Floor Distress Inventory (PFDI-20)) AND * Range score of Patient Global Impression of Improvement (PGI-I) 1 or 2 AND * No need for other treatment for prolapse (surgical nor medical)

次要结局

  • Rate of the prolapse surgery(3 years)
  • Sexual function(1 year)
  • Rate of post-operative complications(45 Days)

研究者

发起方
University Hospital, Limoges
申办方类型
Other
责任方
Sponsor

研究点 (18)

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