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Spots Global Cancer Trial Database for Acetic Acid Colonoscopy Enhancement Study

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Trial Identification

Brief Title: Acetic Acid Colonoscopy Enhancement Study

Official Title: Acetic Acid Colonoscopy Enhancement Study

Study ID: NCT02231385

Interventions

Acetic Acid

Study Description

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:

Eligibility

Minimum Age: 40 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Nuovo Regina Margherita Hospital, Rome, , Italy

Humanitas Research Hospital, Rozzano, Milan, , Italy

Contact Details

Name: Alessandro Repici, MD

Affiliation: Humanitas Research Hospital

Role: PRINCIPAL_INVESTIGATOR

Name: Cesare Hassan, MD

Affiliation: Nuovo Regina Margherita Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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