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

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

Detailed Description
-----------------
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.

Official Title
-----------------
Conventional Endoscopic Mucosal Resection (With Submucosal Injection) Versus Underwater Endoscopic Mucosal Resection (Without Submucosal Injection) for Colorectal Non-pedunculated Colorectal Lesions

Conditions
-----------------
Adenoma, Colorectal Neoplasms

Intervention / Treatment
-----------------
* Procedure: Conventional Endoscopic Mucosal Resection
* Procedure: Underwater Endoscopic Mucosal Resection


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Mucosal Resection<br>C-EMR will be made with saline injection with the indigo carmine. | Procedure: Conventional Endoscopic Mucosal Resection<br>* Conventional Endoscopic Mucosal Resection<br>* Other names: EMR;|
| Experimental: Underwater Mucosal Resection<br>UW-EMR will be made after the complete filling of lumen with water. | Procedure: Underwater Endoscopic Mucosal Resection<br>* Underwater Endoscopic Mucosal Resection<br>* Other names: U-EMR;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success rate |  | three years | 
| Safety (incidence of complications); |  | three years | 
| Local recurrence. |  | Four years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resection rate en bloc |  | three years | 
| Time of resection |  | Three years | 
| Sydney resection ratio (characterized by the following equation - lesion size in millimeters |  | Three years |