Status:
TERMINATED
Piecemeal Versus En Bloc Resection of Large Rectal Adenomas
Lead Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Conditions:
Colorectal Adenoma With Mild Dysplasia
Colorectal Adenoma With Severe Dysplasia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Currently, colonoscopy is the safest way to detect bowel tumors and polyps, since these can be biopsied and removed in one working process. If the size of adenomas is larger than 2 cm, resections are ...
Detailed Description
In 20 to 35% of colonoscopies due to symptoms or for prevention polyps, so-called adenoma, are found. Currently, colonoscopy is the best way to detect bowel tumors and polyps, since these can be biops...
Eligibility Criteria
Inclusion
- patients with large non pedunculated colorectal adenomas designated for endoscopic resection up to 15 cm ab ano, length 2 cm to 5 cm, maximum hemicircumferential
- age \> 18 years
- signed Informed Consent
Exclusion
- adenomas smaller or larger than described above
- more than one large rectal adenoma
- adenomas with known or suspected carcinoma, proven by previous biopsies
- adenomas with known or suspected carcinoma that do not seem to be resectable by endoscopy, e.g. ulcers, suspected infiltration of submucosa after endoscopic or ultrasound diagnostics
- patients with chronic inflammatory bowel diseases
- severe general disease, including metastasising carcinomas
- coagulation abnormalities or anticoagulant drug use which make resection therapy impossible
- bad general state of health (American Society of Anesthesiologists Classification (ASA) IV or more)
- pregnancy and lactation
- recurrence or leftover dysplasia after extended endoscopic or surgical therapy (transanal endoscopic microsurgery (TEM))
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2022
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT02238938
Start Date
April 1 2014
End Date
May 30 2022
Last Update
June 29 2023
Active Locations (6)
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1
Sana Klinikum Lichtenberg
Berlin, Germany, 10365
2
Vivantes Wenckebach-Klinikum
Berlin, Germany, 12099
3
University Hospital Eppendorf
Hamburg, Germany, 20246
4
St. Bernward Krankenhaus
Hildesheim, Germany, 31134