Adenoma Colon, Colorectal Cancer
Conditions
Keywords
Colonoscopy, Adenoma, Adenoma detection rate
Brief summary
Evaluation of colonoscopy with a specific device for the detection of adenomas: Multicenter, prospective and randomized study
Detailed description
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.
Interventions
DEVICEColonoscopy
Patients undergoing screening colonoscopy
DEVICEColonoscopy with specific device (Endocuff Vision)
Patients undergoing screening colonoscopy using the Endocuff Vision device
Sponsors
Spanish Clinical Research Network - SCReN
Dr. Alberto Herreros de Tejada Echanojáuregui
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Concealed assignation
Intervention model description
Randomized Multicenter prospective trial with medical device
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All patients must be adults (≥18 years), give their consent for endoscopic exploration, for the study and meet following inclusion criteria: 1. Patients with positive immunologic fecal occult blood test (IFOBT) for population screening. 2. Patients invited to an opportunistic screening colonoscopy or included regional population screening program. 3. Patients with a family history of CRC and indication of screening colonoscopy. 4. Patients with follow-up colonoscopy indication by personal history of adenomas.
Exclusion criteria
1. Patients with absolute contraindications for colonoscopy (suspicion of intestinal obstruction or perforation, acute diverticulitis suspected or confirmed 6 weeks before the colonoscopy, etc). 2. Symptomatic patients with indication of diagnostic colonoscopy. 3. Patients with a personal history of CRC. 4. Patients with a personal history of chronic inflammatory bowel disease (IBD). 5. Patients with a known personal history of hereditary CRC syndrome: I. No polyposis (Lynch syndrome). II. Polypic. 6. Patients with suspected attenuated polyposis (\> 20 adenomas) with genetic diagnosis not defined. 7. Patients with total or partial colic resection. 8. Complete colonoscopy with an adequate preparation (total Boston ≥6 with at least score ≥2 per segment) in a period of less than a year 9. Pregnant or breastfeeding mothers. 10. Patients who have expressed their wish not to participate or who do not have the ability to understand and / or sign informed consent. 11. Patients with any serious and uncontrolled medical, psychological, psychiatric, geographic or social problem that could interfere with the participation of the patient in the study or not allow an adequate follow-up and adherence with the protocol and evaluation of the results of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma detection rate (ADR) | 1 day | Number of adenoma detected by colonoscopy |
| Mean adenoma per procedure (MAP) | 1 day | Mean of adenoma detected by patient |
Secondary
| Measure | Time frame |
|---|---|
| Total number of adenomas detected by colonoscopy | 1 day |
| Total number of advanced adenomas detected by colonoscopy | 1 day |
| Total number of serrated lesions with or without detected dysplasia by colonoscopy | 1 day |
Countries
Spain
Outcome results
None listed