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Oncology & Cancer Care
Opening soonObservationalNCT06902701

Endoscopic Submucosal Dissection vs. Transanal Endoscopic Surgery for Rectal Neoplasia

Early rectal tumors can be removed either through the colonoscope (endoscopic submucosal dissection) or by minimally invasive transanal surgery. This study compares the two approaches for completeness of removal, complications and recurrence.

SponsorTurkish Society of Colon and Rectal Surgery
Study typeObservational
Started2025-07-01
Primary completion2027-06-01
Planned enrolment156
Sites1 Acıbadem · 4 other

Endoscopic Submucosal Dissection vs. Transanal Endoscopic Surgery for Rectal Neoplasia: A Multicenter Prospective Observational Cohort Study

What this study is about

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.

+Read the 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 greater focus on organ-preserving treatment options, with endoscopic submucosal dissection (ESD) and transanal endoscopic surgery (TES) emerging as key techniques for local excision. ESD allows for en bloc resection of superficial lesions with high histological completeness but has a steep learning curve and a higher perforation risk. In contrast, TES, performed using transanal minimally invasive surgery (TAMIS) or transanal endoscopic operation (TEO), facilitates full-thickness excision and is more commonly used in Western surgical practice.

Each technique presents unique advantages and challenges. ESD is minimally invasive, preserves rectal function, and reduces postoperative complications such as fecal incontinence. However, its prolonged procedure time and technical difficulty limit its widespread adoption. TES, utilizing standard laparoscopic instruments, offers superior visualization and facilitates excision of deeper lesions but may lead to rectal wall defects, increased postoperative pain, and anorectal dysfunction. While studies suggest similar en bloc and recurrence rates between the two methods, discrepancies exist in procedural efficiency, hospital stay, and morbidity rates, with ESD potentially offering a shorter hospitalization period in certain cases.

Despite th...

Conditions
  • Rectal Neoplasms
Interventions
  • Endoscopic Submucosal Dissection (ESD)
  • Transanal Endoscopic Surgery (TES)
Primary outcome measures
  • R0 Resection Rate — Immediately post-procedure.
  • Recurrence Rate — 12 months post-procedure.
Who can take part
SexAllAge18 Years to no upper limitHealthy volunteersNo
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)

Criteria are written for physicians. Do not rule yourself out: send your reports and the study team will check.

Acıbadem study sites
  • Acıbadem Kent Hospital, Izmir

Also running at 4 other sites in 1 countries.

Source: ClinicalTrials.gov NCT06902701 · last updated 2025-06-24 · View registry record ↗