Multicentre, randomised controlled trial comparing TRansanal minimal InvAsive Surgery (TAMIS) and endoscopic Submucosal dIsseCtion (ESD) for resection of non-pedunculated rectal lesions.
- Conditions
- Rectal polyps. Rectal adenoma100179901001799110017998
- Registration Number
- NL-OMON53125
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 198
- 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
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method