Open, Randomized, Prospective, Comparative, Multicentric to Treat Prolapse of Vaginal Cuff After Hysterectomy With Amreich Procedure or Total Prolift Procedure
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 10
- 主要终点
- The objective evaluation o perioperative complications and comparison of patients with pelvic organ prolapse treated with Amreich-Richter procedure or Prolift implants.
研究概览
简要总结
Head to Head comparison of perioperative complications and secondary the impact of operation techniques with or without mesh on patients suffering from pelvic organ prolapse on quality of life.
详细描述
During the last decade a substantial progress in the detailed knowledge of morphology and function of different compartments of the female pelvic floor was achieved. The obtained informations were quickly implemented in the clinical practice especially in the application of special meshes and of novel techniques of their implantation. Their success rate was evaluated only in pilot companies supported studies. We do miss randomised studies not sponsored by company comparing different surgical techniques and their impact on the quality of life (QoL); the objective estimation of those consequences is for the longlasting effect of the surgery inevitable. The new methods bring also new complications which were not yet relevantly and objectively documented.
In the study we compare the techniques contemporary used - in the groups with or without mesh, in size relevant for the statistical evaluation
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female sex
- •age 18 and more
- •subscribed informed consent
- •objective symptoms of prolapse-POP-Q 3 and more according to ICS standards
- •compliance of the patient
排除标准
- •patients with evidence of malignant lesion in small pelvis
- •history of radiotherapy in small pelvis
- •patients suffering from any form of PID within inclusion process
- •pregnancy
- •lactation
- •total eversion of uterus and vagina
- •serious internal disorders
- •history of recto- or vesico-vaginal fistula
- •history of rejection of any artificial material
- •symptoms of primary genuine stress urinary incontinence
- •patients who were not able to subscribe the informed consent
- •patients, who couldn´t be reached for further follow-up
结局指标
主要结局
The objective evaluation o perioperative complications and comparison of patients with pelvic organ prolapse treated with Amreich-Richter procedure or Prolift implants.
时间窗: 3 month
次要结局
- Ultrasound, urodynamics, clinical examinations, magnetic resonance imaging, validated QoL questionnaires(1 year)