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临床试验/NCT03667521
NCT03667521已完成不适用

Prospective Cross-sectional Study on the Prevalence of Stool Outlet Obstruction After Laparoscopic Sacrocolpopexie at the KSA

Kantonsspital Aarau0 个研究点目标入组 55 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
55
主要终点
the number of de novo or worsened obstructed defecation

研究概览

简要总结

The aim was to evaluate the prevalence of stool outlet obstruction after laparoscopic sacrocolpopexie at the Kantonsspital Aarau in a prospective cross-sectional study.

Laparoscopic sacrocolpopexy techniques involving the dissection of the presacral space can compromise fibers of the superior hypogastric plexus. This can contribute to postoperative problems such as incomplete voiding, defecatory dysfunction, pain, and sensory problems. In 2010, the Kantonsspital Aarau has implemented a new nerve-sparing laparoscopic sacrocolpopexy technique. This technique has subjectively reduced the prevalence of stool outlet obstructions but this has not been tested systematically yet. The aim of this study is therefore to compare the patients' subjective conditions between these two surgical techniques using the investigator's standard-of-care German pelvic floor questionnaire.

详细描述

The (pre-) sacral space is characterized by a complex neuroanatomy and surgical intervention in this part of the body is often associated with the dissection of nerve bundels, a procedure which may finally lead to transient defecatory dysfunction. In a earlier study we could show that ~17.8% of patient with laparoscopic sacrocolpopexie developed postoperative constipation within 3-6 months. In november 2010 the Frauenklinik Aarau introduced a novel, nerve-sparing technique of laparoscopic sacrocolpopexie. In this study we assess the pre-and postoperative differences in defecatory dysfunction between the two procedures trough the analysis of our standard of care pelvic floor questionnaire.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • Women affected by symptomatic vault prolapse, who underwent laparoscopic sacrocolpopexy at the KSA
  • informed consent

排除标准

  • participation in other studies
  • Sacrocolpopexie done by Da Vinci Roboter
  • Patients who had a conversion to laparotomy perioperatively
  • Patients with a recurrence who had to undergo a second surgery
  • Patients who had a relaps operation

结局指标

主要结局

the number of de novo or worsened obstructed defecation

时间窗: 2003-2017

comparison of the number of de novo or worsened obstructed defecation of a cohort of patients who underwent nerve-sparing laparaoscopic sacrocolpopexy versus patients who underwent non-nerve-sparing laparaoscopic sacrocolpopexy

次要结局

未报告次要终点

研究者

发起方
Kantonsspital Aarau
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dimitri Sarlos

Head of the Womens Hospital Kantonsspital Aarau, chief of gynecology and gyn. oncology, head of the breast and gyn. tumor center

Kantonsspital Aarau

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