Conventional Endoscopic Mucosal Resection vs Underwater Resection for Colorectal Non-pedunculated Colorectal Lesions

Instituto do Cancer do Estado de São Paulo105 enrolled

Overview

Randomized, comparative and prospective study between Conventional Endoscopic Mucosal Resection for the removal of flat or sessile colorectal lesions without previous attempt to resection.

This prospective randomized trial was conducted in 2 academic services: Instituto do Câncer do Estado de São Paulo and Centro de Diagnóstico em Gastroenterologia, both linked to the University of São Paulo. The clinical study was performed in accordance to the Declaration of Helsinki.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

105

Conditions

Adenoma Colorectal Neoplasms

Interventions

Conventional Endoscopic Mucosal ResectionPROCEDURE

Conventional Endoscopic Mucosal Resection

Underwater Endoscopic Mucosal ResectionPROCEDURE

Underwater Endoscopic Mucosal Resection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients age \>18 years with sessile or flat Colorectal Lesions (measuring between 10 and 40mm), who consent to this study Exclusion Criteria: * Patients who refuse to participate in the study. * Patients with pedunculated, depressed or mixed lesions. * Patients with lesions smaller than 10 mm or larger than 40 mm. * Patients with lesions that are inflammatory, neuroendocrine or stromal at the pathology. * Patients with lesions that were submitted to prior attempt to endoscopic resection.

Locations (1)

Instituto do Cancer do Estado de Sao Paulo

São Paulo, Brazil

Outcomes

Primary Outcomes

Technical success rate

Time frame: three years

Safety (incidence of complications);

Time frame: three years

Local recurrence.

Time frame: Four years

Secondary Outcomes

Resection rate en bloc

Time frame: three years

Time of resection

Time frame: Three years

Sydney resection ratio (characterized by the following equation - lesion size in millimeters

Time frame: Three years

Data from ClinicalTrials.gov

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