Endoscopic Submucosal Dissection vs. Transanal Endoscopic Surgery for Rectal Neoplasia

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTurkish Society of Colon and Rectal Surgery

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)

Treatment groups

156 Participants
are divided into 2 treatment groups