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Brief Title: Acetic Acid Colonoscopy Enhancement Study
Official Title: Acetic Acid Colonoscopy Enhancement Study
Study ID: NCT02231385
Brief Summary: The purpose of this study is to compare the additional diagnostic yield obtained by using the acetic acid as vital substance to improve the detection of serrated lesions at colonoscopy. Patients who are scheduled for screening, surveillance or diagnostic colonoscopy will be recruited to the study and randomized to one of two groups. Each enrolled subject will undergo two "back-to-back" procedures limited to the examination of the right colon. Subjects in Group A (study group) will undergo a standard colonoscopy. Once the right colon has been fully examined, acetic acid 2% will be sprayed and the right colon re-examined from cecum to hepatic flexure with within a frame-time of two minutes. Subjects in Group B (control group) will undergo a second examination of the right colon without acid acetic and within the same frame-time. Results from the two groups will be analyzed and compared, with primary outcome measures being detection rates for serrated lesions. Secondary outcome measures will include adenoma detection rate in the right colon or other locations, characteristics of polyps detected, including size and histological results. Subjects will be followed through a 24-72 hour telephone interview for analysis of unexpected adverse events. Clinical results will be analyzed using various statistical measures of significance.
Detailed Description:
Minimum Age: 40 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Nuovo Regina Margherita Hospital, Rome, , Italy
Humanitas Research Hospital, Rozzano, Milan, , Italy
Name: Alessandro Repici, MD
Affiliation: Humanitas Research Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Cesare Hassan, MD
Affiliation: Nuovo Regina Margherita Hospital
Role: PRINCIPAL_INVESTIGATOR