TRANSANAL ENDOSCOPIC MICROSURGERY VERSUS ENDOSCOPIC MUCOSAL RESECTION FOR LARGE RECTAL ADENOMAS

Phase 3

Recruiting

• Conditions: rectal adenoma; rectal polyp; 10017934

• Registration Number: NL-OMON32240
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 186

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1) proportion of patients with adenoma recurrence after 3 months; 2) number of<br /><br>days not spent in hospital from initial treatment until 2 years afterwards;<br /><br>adenoma recurrence after 3 months is defined as treatment failure.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>3) morbidity, subdivided into major (requiring surgery) and minor (requiring<br /><br>endoscopic or medical intervention); 4) disease specific and general quality of<br /><br>life; 5) anorectal function; 6) health care utilization and costs.</p><br>