About this trial
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 treatment of early-stage rectal neoplasia. The study will evaluate recurrence rates, en bloc resection rates, R0 resection rates, procedure time, complication rates, and length of hospital stay over a 1-year follow-up period. Data will be collected from patients treated at multiple centers with expertise in ESD and TAMIS.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Endoscopic Submucosal Dissection (ESD)
- Transanal Endoscopic Surgery (TES)