In a randomized trial we will compare the cost-effectiveness and cost-utility of TEM and EMR for the resection of large rectal adenomas.
ID
Source
Brief title
Condition
- Benign neoplasms gastrointestinal
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Recent non-randomized studies suggest that extended endoscopic mucosal
resection (EMR) is equally effective in removing large rectal adenomas as
transanal endoscopic microsurgery (TEM). If equally effective, EMR might be a
more cost-effective approach as this strategy does not require expensive
equipment, general anesthesia and hospital admission. Furthermore, EMR appears
to be associated with fewer complications. In a randomized trial we will
compare the cost-effectiveness and cost-utility of TEM and EMR for the
resection of large rectal adenomas.
Study objective
In a randomized trial we will compare the cost-effectiveness and cost-utility
of TEM and EMR for the resection of large rectal adenomas.
Study design
13 Dutch expertise centers will participate in this multicenter randomized
trial comparing TEM versus EMR.
Intervention
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 admitted to the hospital.
EMR: without sedation (or conscious sedation only), an endoscope is inserted
into the rectum and the submucosa underneath the lesion will be injected with
saline to lift the adenoma. With an endoscopic snare the lesion will be
resected through the submucosal plane in a piecemeal fashion, after which the
patient will be discharged from the hospital. Residual adenomatous disease
visible during the first surveillance endoscopy at 3 months will be removed
endoscopically in both strategies and is considered as part of the primary
treatment.
Study burden and risks
All patients will undergo standard treatment and follow-up. The only adjustment
to current clinical practice will be the randomization which determines the
treatment strategy (TEM versus EMR).
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
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 <15cm from the anal verge, respectively.
(3) Biopsies of the lesion did not show invasive cancer.
(4) No endoscopic or endoscopic ultrasonographic suspicion for invasive cancer
(5) Synchronous colonic adenomas or cancers are excluded by colonoscopy first.
(6) The general health condition of the patient permits general/spinal anesthesia (ASA I-III).
(7) Absence of non-correctable coagulopathy
(8) Patient age of 18 years or older.
Exclusion criteria
(1) Suspicion for invasive cancer during endoscopy or endoscopic ultrasonography
(2) Proven invasive cancer with biopsies (histology)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL23846.018.08 |