Adenoma, Colorectal Neoplasms
Conditions
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.
Interventions
Conventional Endoscopic Mucosal Resection
Underwater Endoscopic Mucosal Resection
Sponsors
University of Sao Paulo
Instituto do Cancer do Estado de São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Technical success rate | three years |
| Safety (incidence of complications); | three years |
| Local recurrence. | Four years |
Secondary
| Measure | Time frame |
|---|---|
| Time of resection | Three years |
| Resection rate en bloc | three years |
| Sydney resection ratio (characterized by the following equation - lesion size in millimeters | Three years |
Countries
Brazil
Outcome results
None listed