Registration study Rectal cancer Rectal adenoma Endoscopic submucosal dissection Transanal Minimally Invasive Surgery Endeldarm kanker Endeldarm poliep
Conditions
Interventions
In this observational side study of the TRIASSIC trial patients will either undergo resection by the TAMIS technique or by the ESD technique.
Sponsors
Leiden University Medical Centre
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence rate at follow-up colonoscopy at 6 and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| • En bloc resection rate, defined as macroscopic removal of the lesion in a single piece • Radical (R0-) resection rate, defined as dysplasia free vertical and lateral resection margins at histology for benign lesions • Radical (R0-) resection rate, defined as dysplasia free vertical and lateral resection margins at histology for invasive lesions • Surgical referral rate at 12 months • Complication rate | — |
Contacts
Public ContactNik Dekkers
LUMC
Outcome results
None listed