Multicenter Study on Levator Ani Muscle Fixation in Laparoscopic Colposacropexy (FIMEA Multicenter Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 190
- 试验地点
- 6
- 主要终点
- Difference in anatomical success rate between simplified (Group B) and standard (Group A) laparoscopic colposacropexy.
研究概览
简要总结
This is a prospective, randomized, multicenter, non-inferiority trial including women with stage II-IV apical pelvic organ prolapse (POP), classified according to the POP-Q system. Participants will be randomized into two groups:
Group A: laparoscopic colposacropexy with posterior mesh fixation to the levator ani muscle.
Group B: laparoscopic colposacropexy with posterior mesh fixation to the vaginal cuff/cervix, without dissection of the rectovaginal space.
The objective of the study is to determine whether a simplified colposacropexy technique is non-inferior to the standard procedure in terms of anatomical and functional outcomes.
The primary outcome is anatomical success, defined as a postoperative POP-Q stage 0-I. Secondary outcomes include functional status and sexual function, evaluated using the PFDI-20 and PISQ-12 questionnaires. Data on prolapse anatomy, related symptoms, and sexual function will be collected at baseline and during follow-up visits at 1, 6, and 12 months after surgery.
This study is supported by a national health research grant from the Instituto de Salud Carlos III (ISCIII), Ministry of Science and Innovation, Spain.
详细描述
This study is a multicenter, randomized, controlled, evaluator-blinded, non-inferiority clinical trial. The null hypothesis is that colposacropexy with posterior mesh fixation to the vaginal vault (without rectovaginal dissection) is associated with an anatomical and/or functional failure rate that is equal to or more than 15% higher than colposacropexy with posterior mesh fixation to the levator ani muscle (deep rectovaginal dissection). A non-inferiority margin of 15% has been selected because smaller differences are not considered clinically relevant.
With this project, the investigators aim to evaluate the outcomes of a simplified colposacropexy technique that avoids dissection of the rectovaginal space and deep pelvic mesh fixation. Demonstrating non-inferiority would imply rejecting the null hypothesis.
The procedure is indicated for women with stage II-IV uterine or vault prolapse according to the POP-Q classification, with or without associated anterior and/or posterior vaginal wall defects. The decision to perform surgery will be made by the gynecologists, independent of trial participation, to ensure that study enrollment does not influence standard surgical indications. Exclusion criteria include previous abdominal or vaginal mesh prolapse reconstructive surgery or POP-Q stage I or asymptomatic prolapse.
Sample size calculations assume a 91% success rate for the standardized procedure (Lee 2014), a non-inferiority margin of 15%, a 95% confidence interval, and 80% statistical power. A total of 166 patients (83 per group) are required, accounting for a 10% dropout rate.
DESCRIPTION OF THE SURGICAL TECHNIQUE
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, Outcomes Assessor)
盲法说明
Due to the nature of the surgical intervention, a double-blind design is not feasible. However, the assessment of anatomical and functional outcomes during follow-up will be performed by an evaluator who is blinded to the type of surgical technique used.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with primary or recurrent apical prolapse (uterine or vaginal vault) stage II-IV according to the POP-Q classification.
- •Women with symptomatic POP with indication of reconstructive POP surgery.
- •Agreement to comply with all scheduled visits and assessments through 12 months post-surgery.
- •Understand and accept the study procedures and sign the informed consent.
排除标准
- •History of abdominal reconstructive surgery for pelvic organ prolapse.
- •History of vaginal reconstructive surgery for prolapse using mesh.
- •Stage I prolapse according to the POP-Q classification, or asymptomatic prolapse.
- •Medical contraindication to general anesthesia.
- •Patient preference for vaginal surgical treatment.
- •Declines participation in the study.
- •Patients with disabilities or unable to understand the terms of the study.
研究组 & 干预措施
Group A: Standard laparoscopic colposacropexy
The procedure is based on the laparoscopic colposacropexy technique described by Wattiez in 2001 (Clermont-Ferrand group).
The standard technique includes dissection of the sacral promontory, the vesicovaginal space, and the rectovaginal space with bilateral pararectal fossae.
In the vesicovaginal space, the mesh is anchored deeply at the level of the vesical neck, and posteriorly, in the rectovaginal and pararectal spaces, at the level of the levator ani muscle.
干预措施: Laparoscopic colposacropexy with levator ani muscle mesh fixation (Procedure)
Group B: Simplified laparoscopic colposacropexy
The simplified technique includes dissection of the sacral promontory and the vesicovaginal space, but does not involve dissection of the rectovaginal space or the pararectal fossae. In this technique, the posterior mesh is anchored to the posterior aspect of the vaginal vault or cervix. Mesh fixation at the sacral promontory and in the vesicovaginal space is performed within the same anatomical boundaries as in the standard technique.
干预措施: Simplified modification of laparoscopic colposacropexy (Procedure)
结局指标
主要结局
Difference in anatomical success rate between simplified (Group B) and standard (Group A) laparoscopic colposacropexy.
时间窗: 12 months after surgery
Proportion of participants achieving anatomical success, defined as postoperative POP-Q stage 0-I. The primary analysis will test non-inferiority of the simplified technique (Group B) versus the standard technique (Group A). Non-inferiority will be concluded if the lower bound of the two-sided 95% confidence interval for (Success\_B - Success\_A) is greater than 15% (non-inferiority margin = 15%). POP-Q assessment will be performed using standardized technique by an evaluator blinded to surgical assignment.
次要结局
- Difference in functional outcomes between simplified (Group B) and standard (Group A) laparoscopic colposacropexy.(12 months after surgery)
- Difference in sexual outcomes between simplified (Group B) and standard (Group A) laparoscopic colposacropexy.(12 months after surgery)
研究者
IRENE MORA HERVAS
Coordinator of the Pelvic Floor Functional Unit at the Hospital de la Santa Creu i Sant Pau
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau