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
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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