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NCT06902701Not yet recruiting

Endoscopic Submucosal Dissection vs. Transanal Endoscopic Surgery for Rectal Neoplasia

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

Source: ClinicalTrials.gov · Last updated 24 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
156 (estimated)
First submitted
16 Mar 2025
Start date
1 Jul 2025
Primary completion date
1 Jun 2027
Lead sponsor
Turkish Society of Colon and Rectal Surgery
NCT number
NCT06902701

What you commit to

  • Study type: Observational
  • Planned participants: 156
  • From 1 Jul 2025 to the primary completion date, 1 Jun 2027
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous attempt at endoscopic resection
  • Previous rectal surgery
  • Previous pelvic radiation therapy

Other illness

  • Inflammatory bowel diseases (Crohn's disease, Ulcerative colitis)

Other

  • Evidence of lymph node involvement, T2 rectal tumors, or distant metastasis on preoperative imaging modalities (MRI, ERUS, CT)

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Private Office
Coordinator of this site? Confirm its status
IstanbulTurkey (Türkiye)Unknown status
Memorial Sisli Hospital
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IstanbulTurkey (Türkiye)Unknown status
Baskent University
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IstanbulTurkey (Türkiye)Unknown status
Acibadem Kent Hospital
Coordinator of this site? Confirm its status
IzmirTurkey (Türkiye)Unknown status
Dokuz Eylul University
Coordinator of this site? Confirm its status
IzmirTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.