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Endoscopic Submucosal Dissection vs Local Laparoscopic Surgical Resection (TAMIS/TEO) in Early Rectal Neoplasias

NCT03959839 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-06-03

No results posted yet for this study

Summary

A multicenter non-inferiority randomized clinical trial to compare Endoscopic treatment (ESD) and Minimally Invasive Laparoscopic Local Surgical Treatment (TAMIS or TEO) for early rectal neoplastic lesions (adenoma \& T1CRC) Primary aim: To compare the long-term local recurrence rate (12 months after the procedure)

Secondary aims:

Compare en-bloq resection rate, R0 resection, time per procedure, short-term recurrence rate, safety (rate of complications), morbidity and cost-effectiveness analyses.

Conditions

  • Rectal Neoplasms

Interventions

PROCEDURE

ESD

Rectal Endoscopic Submucosal Dissection

PROCEDURE

TAMIS

Transanal Minimally Invasive Surgery

PROCEDURE

TEO

Transanal Endoscopic Operation

Sponsors & Collaborators

  • Spanish Society of Digestive Endoscopy

    collaborator OTHER

  • Dr. Alberto Herreros de Tejada Echanojáuregui

    lead OTHER

Principal Investigators

  • Eduardo Albéniz, MD, PhD · Complejo Hospitalario de Navarra

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2024-12-20
Completion
2024-12-20

Countries

  • Spain

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 NCT03959839 on ClinicalTrials.gov