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临床试验/NCT05992948
NCT05992948招募中不适用

Endosonograpic Monitoring of Injury to the Anal Sphincter After Transanal Stapled Anastomosis

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年1月1日最近更新:
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适应症

试验速览

阶段
不适用
状态
招募中
入组人数
90
试验地点
1
主要终点
EAUS
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Investigation of the sphincter muscles after low anterior or anterior rectum resection, and sigma resection operation by endoluminal ultrasound and manometrical examination.

研究设计

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

入排标准

年龄范围
18 Years 至 90 Years（Adult, Older Adult）
性别
All
接受健康志愿者
是

入选标准

  • •Age 18 - 90 years, undergoing transanal stapled anastomosis at the Department of General Surgery, Medical University of Vienna
  • •Ability and willingness to understand and comply with study interventions and restrictions.
  • •Voluntarily signed informed consent after full explanation of the study to the participant.

排除标准

  • •Any physical or mental disorder, which could interfere with the participant's safety during the clinical trial or with the study objectives
  • •Inability to communicate well with the investigator due to language problems or reduced mental development
  • •Inability or unwillingness to give written informed consent

结局指标

主要结局

EAUS

时间窗: 3 months postoperative

Change in thickness of the anal sphincter muscles in mm from baseline to 3 months

次要结局

  • Endoanal manometry(3 months postoperative)
  • EAUS2(3 months postoperative)
  • Endoanal manometry2(12 months postoperative)
  • EAUS2-2(12 months postoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Christopher Dawoud

Principal Investigator; MD

Medical University of Vienna

研究点 (1)

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