ESD and TAMIS: Results from a multicenter study

Recruiting

Conditions: Registration studyRectal cancerRectal adenomaEndoscopic submucosal dissectionTransanal Minimally Invasive SurgeryEndeldarm kankerEndeldarm poliep

Registration Number: NL-OMON23611

Lead Sponsor: eiden University Medical Centre

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

• Unwillingness to participate in the TRIASSIC study (Trial NL7083; NTR7281)
• Non pedunculated polyp >2cm in the rectum, where the bulk of the lesion is below 15cm
from the anal verge found at colonoscopy
• =18 years old

Exclusion Criteria

• Features of advanced disease or deep-submucosal invasion at optical endoscopic
evaluation.
• 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.
• Prior endoscopic resection attempt
• The risk exceeds the benefit of endoscopic treatment, such as patients with an
extremely poor general condition or a very short life expectancy
• The inability to provide informed consent

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence rate at follow-up colonoscopy at 6 and 12 months.

Secondary Outcome Measures

Name	Time	Method
• En bloc resection rate, defined as macroscopic removal of the lesion in a single piece<br>• Radical (R0-) resection rate, defined as dysplasia free vertical and lateral resection<br>margins at histology for benign lesions<br>• Radical (R0-) resection rate, defined as dysplasia free vertical and lateral resection<br>margins at histology for invasive lesions<br>• Surgical referral rate at 12 months<br>• Complication rate