跳至主要内容
临床试验/NCT04478747
NCT04478747招募中不适用

Women's Apical Pelvic Organ Prolapse Treatment - a Randomized Controlled Trial Comparing Transvaginal and Laparoscopic Mesh Surgery

Helsinki University Central Hospital1 个研究点 分布在 1 个国家目标入组 318 人开始时间: 2020年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
318
试验地点
1
主要终点
Subjective success; defined as the absence of vaginal bulge

研究概览

简要总结

The main objective of the study is to compare subjective efficacy of trans vaginal mesh and laparoscopic colposakropexy (CSP) in women with an apical prolapse. The CSP group is further divided into two sub-groups; one where the mesh fixation is only at the apical part of the vagina, and another where the fixation is also extended to the levator plane.

The secondary outcomes are safety (peri- and post-surgery complications, pain, erosion), objective efficacy (simplified POP-Q), and re-operation rate. Subjective outcome also includes the assessment of sexual satisfaction. Cost-effectiveness is studied by comparing both direct costs and QALYs.

详细描述

Pelvic organ prolapse (POP) is defined as an anatomical support defect of the pelvic viscera. Women's POP is the descent of uterus or vaginal apex with or without concomitant descent of the anterior (cystocele) or posterior (rectocele) vaginal wall. It is estimated that the lifetime risk of POP surgery in women is approximately 10-13%, the incidence peak being 20-30 years after the first delivery, which is also the most important risk factor for POP. Other risk factors include previous hysterectomy, obesity and genetic factors.

The typical POP symptoms are a feeling of bulge, accompanied with urinary incontinence, defecation problems, and sexual dissatisfaction. First line treatments are conservative, but if they fail, surgery is indicated.

Native tissue repair of the anterior and / or posterior vaginal wall (colporrhaphy anterior / posterior) is commonly the first-line operation. The possible concomitant apical prolapse needs to be suspended which is typically done by either by performing a hysterectomy with shortening and suspension of the sacrouterine ligaments, or by amputation of the cervix with suspension of the cardinale and sacrouterine ligaments (Manchester operation). An unsuspended apical defect will double the relapse rate (20 vs 11%). In most of the apical recurrences mesh is used to achieve sufficient support. The re-operation rate of any POP in Finland is 10.8% .

In mesh operations the apex can be suspended either transvaginally (TVM) by anchoring the mesh to the sacrospinosus ligaments, or by doing a colposacropexy (CSP) where the mesh is attached to the sacrum, mostly via laparoscopy. The CSP techniques vary e.g. the mesh can be attached only apically or also to the levator plane. If needed, colporrhaphies can be done concomitantly.

The use of TVM has decreased due to the FDA-warnings and litigations concerning mainly the risks of erosion and pain. This has lead to withdrawals of mesh products, despite well-conducted clinical studies indicating that in well-chosen women light-weight small TVM is not associated with major complications. Currently, no TVM with good quality clinical data is available. Traditionally, CSP has been considered safer than TVM in regard of erosions and pain, but the data is scarce. Furthermore, CSP has a longer learning-curve and is a more time-consuming operation than TVM, whereas hospital stay is shorter.

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
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Age over 18 years and capability to understand the study protocol either in Finnish or Swedish.
  • •Objectively diagnosed symptomatic apical prolapse (leading apical prolapse (points C/D) ≥ -2) and a history of previous POP operation including hysterectomy.
  • •No need for any other concomitant operations except colporrhaphies and possible prophylactic salpingo-oophorectomy in CSP groups

排除标准

  • •A history of serious or prolonged pain after any operation or current or previous prolonged (over 6 months) pain of any reason.
  • •BMI over 40
  • •Regular use of systemic corticosteroid medication.
  • •Incapability to understand the study protocol.

研究组 & 干预措施

Transvaginal mesh

Active Comparator

BSC mesh (A.M.I., Feldkirch, Austria) is attached to the sacrospinosus ligaments and to the apical part of the vagina.

干预措施: TVM (Procedure)

Colposacropexy with the apical fixation only

Active Comparator

EndoGYNious (A.M.I.) CSP mesh is attached laparoscopically to the apical part of the vagina.

干预措施: Colposacropexy (Procedure)

Colposacropexy with the apical and the levator fixation

Active Comparator

EndoGYNious (A.M.I.) CSP mesh is attached laparoscopically to the apical part of the vagina with fixation reaching to the level of the levator planes.

干预措施: Colposacropexy (Procedure)

结局指标

主要结局

Subjective success; defined as the absence of vaginal bulge

时间窗: 5 years

Negative response to PDFI-20, question 3, at one-year following the surgery

次要结局

  • Peri and post-operative complications(1 year)
  • Post-operative pain(1 year)
  • Objective efficacy(1 year)
  • Re-operation rate(1 year)
  • Cost-effectiveness(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Camilla Isaksson

Senior consultant

Helsinki University Central Hospital

研究点 (1)

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