Status:
NOT_YET_RECRUITING
Endoscopic Submucosal Dissection vs. Transanal Endoscopic Surgery for Rectal Neoplasia
Lead Sponsor:
Turkish Society of Colon and Rectal Surgery
Conditions:
Rectal Neoplasms
Eligibility:
All Genders
18+ years
Brief Summary
This prospective observational cohort study aims to compare the clinical and procedural outcomes of Endoscopic Submucosal Dissection (ESD) and Transanal Minimally Invasive Surgery (TAMIS) for the trea...
Detailed Description
Colorectal cancer (CRC) is one of the most common malignancies globally, with early-stage rectal neoplasms being increasingly diagnosed due to widespread screening programs. This trend has led to a gr...
Eligibility Criteria
Inclusion
- Adult patients (\>18 years)
- Non-pedunculated (sessile) lesions larger than 2 cm.
- Lesions located within 15 cm from the anal verge confirmed by sigmoidoscopy or magnetic resonance imaging (MRI)
Exclusion
- Evidence of lymph node involvement, T2 rectal tumors, or distant metastasis on preoperative imaging modalities (MRI, ERUS, CT)
- Previous attempt at endoscopic resection
- Previous rectal surgery
- Previous pelvic radiation therapy
- Inflammatory bowel diseases (Crohn's disease, Ulcerative colitis)
Key Trial Info
Start Date :
July 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT06902701
Start Date
July 1 2025
End Date
July 1 2028
Last Update
June 24 2025
Active Locations (5)
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1
Private Office
Istanbul, Turkey (Türkiye), 34394
2
Baskent University
Istanbul, Turkey (Türkiye)
3
Memorial Sisli Hospital
Istanbul, Turkey (Türkiye)
4
Dokuz Eylul University
Izmir, Turkey (Türkiye), 35330