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Endoscopic Submucosal Dissection vs. Transanal Endoscopic Surgery for Rectal Neoplasia

NCT06902701 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 156

Last updated 2025-06-24

No results posted yet for this study

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.

Conditions

  • Rectal Neoplasms

Interventions

PROCEDURE

Endoscopic Submucosal Dissection (ESD)

Endoscopic excision of the rectal lesion by submucosal injection and circumferential mucosal incision using an electrosurgical knife with en-bloc resection intent

PROCEDURE

Transanal Endoscopic Surgery (TES)

Transanal endoscopic surgery procedures include Transanal Minimally Invasive Surgery (TAMIS) and Transanal Endoscopic Operation (TEO). TAMIS will be performed using a single-port transanal access platform with standard laparoscopic instruments, including a high-definition camera, an insufflation system, and endoscopic graspers. The lesion will be circumferentially excised using electrocautery or an energy device, ensuring full-thickness resection when necessary. The defect will be managed based on its size, with primary closure using absorbable sutures or left to heal by secondary intention. TEO will be conducted using a rigid transanal endoscopic platform with a stereoscopic optical system to enhance visualization. The lesion will be marked, and a full-thickness or submucosal excision will be performed using endoscopic instruments and electrosurgical devices. Post-resection, the rectal wall defect will be assessed, and primary closure will be performed when indicated to minimize post

Sponsors & Collaborators

  • Turkish Society of Colon and Rectal Surgery

    lead OTHER

Principal Investigators

  • Feza Karakayali, MD · Baskent University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2027-06-01
Completion
2028-07-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06902701 on ClinicalTrials.gov