Conventional Endoscopic Mucosal Resection vs Underwater Resection for Colorectal Non-pedunculated Colorectal Lesions
Not Applicable
Completed
- Conditions
- Colorectal NeoplasmsAdenoma
- Registration Number
- NCT03021135
- Lead Sponsor
- Instituto do Cancer do Estado de São Paulo
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Safety (incidence of complications); three years Technical success rate three years Local recurrence. Four years
- Secondary Outcome Measures
Name Time Method Time of resection Three years Sydney resection ratio (characterized by the following equation - lesion size in millimeters Three years Resection rate en bloc three years
Trial Locations
- Locations (1)
Instituto do Cancer do Estado de Sao Paulo
🇧🇷Sao Paulo, Brazil
Instituto do Cancer do Estado de Sao Paulo🇧🇷Sao Paulo, Brazil