Not Yet RecruitingNot Applicable

Endoscopic Submucosal Dissection vs. Transanal Endoscopic Surgery for Rectal Neoplasia

Turkey (Türkiye)156 participantsStarted 2025-07-01

Plain-language 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 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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)

What they're measuring

R0 Resection Rate

Timeframe: Immediately post-procedure.

Recurrence Rate

Timeframe: 12 months post-procedure.

Trial details

NCT IDNCT06902701

SponsorTurkish Society of Colon and Rectal Surgery

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-06-01

Contact for this trial

Tayfun Bisgin, MD

+90-2324122901 tayfun.bisgin@gmail.com

View on ClinicalTrials.gov More Rectal Neoplasms trials