Evaluation of colonoscopy with a specific device for the detection of adenomas: Multicenter, prospective and randomized study
Given the discrepancy in the results of the published studies, the main objective of the present study would be to evaluate, through a multicentric design and with a sufficiently large sample of patients, if there are relevant differences in the ADR and in the MAP between the colonoscopy performed with a device specific (Endocuff visionTM) versus standard colonoscopy. Secondarily, the number of adenomas, the number of advanced adenomas and the number of serrated lesions in both groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,453
Patients undergoing screening colonoscopy
Patients undergoing screening colonoscopy using the Endocuff Vision device
Department of Gastroenterology, Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, Madrid, Spain
Department of Gastroenterology, Hospital Universitario La Princesa
Madrid, Spain
Department of Gastroenterology, Hospital General Universitario Gregorio Marañón
Madrid, Spain
Adenoma detection rate (ADR)
Number of adenoma detected by colonoscopy
Time frame: 1 day
Mean adenoma per procedure (MAP)
Mean of adenoma detected by patient
Time frame: 1 day
Total number of adenomas detected by colonoscopy
Time frame: 1 day
Total number of advanced adenomas detected by colonoscopy
Time frame: 1 day
Total number of serrated lesions with or without detected dysplasia by colonoscopy
Time frame: 1 day
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Department of Gastroenterology, Hospital Universitario Ramón y Cajal
Madrid, Spain
Department of Gastroenterology, Hospital Clínico San Carlos
Madrid, Spain
Department of Gastroenterology, Hospital Universitario 12 de Octubre
Madrid, Spain
Department of Gastroenterology, Hospital Universitario La Paz
Madrid, Spain
Department of Gastroenterology, Hospital Universitario Fundacion Alcorcon
Madrid, Spain