rectal adenoma rectal polyp
Conditions
Interventions
TEM: under general anesthesia a TEM tube is inserted in the rectum. With
specialized instruments the adenoma will be dissected en bloc by a full
thickness excision, after which the patient will be a
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: (1) Diagnosed with a large non-pedunculated rectal adenoma with a largest diameter of at least 3cm. (2) The lower and upper borders of the adenoma are located at >1cm and
Exclusion criteria
Exclusion criteria: (1) Suspicion for invasive cancer during endoscopy or endoscopic ultrasonography (2) Proven invasive cancer with biopsies (histology)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) proportion of patients with adenoma recurrence after 3 months; 2) number of days not spent in hospital from initial treatment until 2 years afterwards; adenoma recurrence after 3 months is defined as treatment failure. | — |
Secondary
| Measure | Time frame |
|---|---|
| 3) morbidity, subdivided into major (requiring surgery) and minor (requiring endoscopic or medical intervention); 4) disease specific and general quality of life; 5) anorectal function; 6) health care utilization and costs. | — |
Countries
Netherlands
Outcome results
None listed