Large rectal adenomas of at least 3 cm in diameter
Conditions
Interventions
Transanal endoscopic microsurgery (TEM) according to Buess
and endoscopic mucosal resection (EMR) with submucosal injection of NaCl (according to Karita)
Sponsors
ZonMw
Eligibility
Inclusion criteria
Inclusion criteria: 1. Large non-pedunculated rectal adenoma with a diameter of at least 3cm 2. Located between 1-15cm from the anal verge 3. Biopsies of the lesion did not show invasion of neoplastic tissue in the submucosal layer 4. Flexible video endoscopy or rigid proctoscopy plus endoscopic ultrasonography exclude suspicion of invasive submucosal cancer 5. total colonoscopy will be done to detect and remove all synchronous colonic neoplasia first 6. ASA-classification I-III 7. Absence of non-correctable coagulopathy 8. Patient age of 18 years or older
Exclusion criteria
Exclusion criteria: - See inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Proportion of patients with recurrence (2 year follow up) - The number of days that a patient is alive, outside the hospital and free of recurrence during a two-year follow-up period starting at the day of the initial treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| - Complications - Generic and disease specific healt related quality of life - Costs | — |
Contacts
Public ContactEvelien Dekker
Academic Medical Center (AMC) Department of Gastroenterology and Hepatology P.O. Box 22660
Outcome results
None listed