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临床试验/NL-OMON53125
NL-OMON53125招募中不适用

Multicentre, randomised controlled trial comparing TRansanal minimal InvAsive Surgery (TAMIS) and endoscopic Submucosal dIsseCtion (ESD) for resection of non-pedunculated rectal lesions. - TRIASSIC

eids Universitair Medisch Centrum0 个研究点目标入组 198 人开始时间: 待定最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
198

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 64(—)

入选标准

  • - Non-pedunculated polyp >20mm in the rectum where the bulk of the lesion is
  • below 15cm from the anal verge.
  • - Indication for treatment
  • - >=18 years old
  • - Written informed consent

排除标准

  • o Features of advanced disease or deep submucosal invasion at optical
  • endoscopic evaluation.
  • o Features of advanced disease on cross-sectional imaging. Where there is
  • discordance in the results, the optical endoscopic evaluation will be given the
  • most weight and the case discussed by an expert panel of four study
  • participants.
  • o Prior resection attempt
  • o The risk exceeds the benefit of endoscopic treatment, such as patients with
  • an extremely poor general condition or a very short life expectancy
  • o The inability to provide informed consent
  • (Side-study smartwatch:
  • Wheelchair dependency at baseline
  • Inability to wear or use the wearable device)
  • (Side-study MRI:
  • Contra indication for MRI scan)

研究者

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