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临床试验/NCT00886223
NCT00886223Unknown不适用

Laparoscopic Sacropexy: Clinical Prospective Study With Robot-Assisted Technique(da Vinci®-System)

Kantonsspital Aarau2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2009年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
2
主要终点
Duration of surgery

研究概览

简要总结

The aim of the study is to evaluate safety and outcome of robot-assisted laparoscopic sacropexy regarding perioperative data, objective anatomical results and postoperative quality of life.

详细描述

Vaginal vault prolapse is a common finding in Gynecology. Many different approaches for vaginal vault prolapse repair are available. During the last few years robot-assisted surgery has been introduced in many surgical specialties and experiences in gynecologic surgery are very limited.

Several aspects like the wider range of motion of robot-instruments leading to more precision in surgery, the 3 dimensional optical system and the ergonomically designed console may offer some advantages. For better judgment these possible benefits as well as safety and outcome need to be evaluated and compared with conventional laparoscopic sacropexy techniques.

This prospective clinical study evaluates robot-assisted laparoscopic sacropexy (da Vinci®-System) focusing on peri-operative data, objective anatomical results and postoperative quality of life and compares the results with conventional laparoscopic sacropexy. Pre- peri- and post-operative data are collected using the prolapse quantification system (POP-Q) and the German Pelvic Floor questionnaire. The objective of the study will be to investigate if the robot assisted procedure shows significant advantages for the patient considering duration of surgery, complications, hospitalization, quality of life and costs.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • vaginal vault prolapse
  • recurrence after vaginal prolapse repair
  • signed consent

排除标准

  • rectocele
  • BMI > 40

结局指标

主要结局

Duration of surgery

时间窗: during hospitalisation

次要结局

  • Quality of life(6 months after hospitalisation)
  • Costs(6 months after hospitalisation)
  • Complications(6 months after hospitalisation)
  • Anatomical results(6 months after hospitalisation)

研究者

发起方
Kantonsspital Aarau
申办方类型
Other

研究点 (2)

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