Anatomic and Functional Outcomes of Vaginal Mesh ( ELEVATE) Compared With Laparoscopic Sacrocolpopexy for Pelvic Organ Prolapse
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Functional and anatomical efficacy
研究概览
简要总结
Pelvic prolapse is one of the most frequent pathology in Gynecology. Recurrency of the prolapse after primary surgery is relatively high, 15-30%. Sacrocolpopexy has showed to be effective but it requires a long learning curves and is more aggressive. New meshes techniques seem to be effective, as well, with less learning curve but they are expensive and there are no randomize studies published.
The investigators aim is to compare both techniques in terms of: anatomical and functional efficacy, cost, operating time and complications.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject has been diagnosed with one or more clinically significant anterior, apical, or posterior genital prolapse disorder(s)(symptomatic POP-Q stage II or higher) requiring surgical repair.
排除标准
- •Investigator determines subject is not a candidate for surgical repair of her genital prolapse.
- •Subject has had a prior prolapse procedure involving graft placement (synthetic or biologic)
- •Subject has active or latent systemic infection or signs of tissue necrosis.
- •Subject has restricted leg motion (inability to abduct or adduct leg positioning in the lithotomy position) with or without a hip replacement / prosthesis.
- •Subject is currently pregnant or intends to become pregnant during the study period.
- •Subject has had radiation therapy to the pelvic area.
- •Subject has pelvic cancer, has had pelvic cancer within the past 12 months or has been on cytostatic medication within the past 12 months.
- •Subject has uncontrolled diabetes.
- •Subject is on any medication with could result in compromised immune response, such as immune modulators.
- •Subject has undergone previous pelvic surgery < 6 months prior to enrollment in this study.
- •Subject is unwilling or unable to give valid informed consent.
- •Subject is unwilling or unable to comply with the requirements of the protocol, complete all quality of Life questionnaires and return for all follow-up visits.
- •Subject with contraindications for laparoscopy
研究组 & 干预措施
Elevate meshes
The use of Elevate (American Systems trade mark) meshes for the treatment of pelvic prolapse.
干预措施: Elevate mesh (Device)
Sacrocolpopexy
Sacrocolpopexy for the correction of the prolapse
干预措施: Sacrocolpopexy (Device)
结局指标
主要结局
Functional and anatomical efficacy
时间窗: 1 year
次要结局
- operating time, cost and complications of both techniques(6 months)
研究者
Francisco Carmona
Chief of Department of OB GYN
Hospital Clinic of Barcelona