An interventional study of Acetic Acid in Colorectal Cancer, Serrated Adenomas and Colon Nos Polypectomy Tubular Adenoma, sponsored by Istituto Clinico Humanitas. Status unknown at 2 sites in Italy. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2014-09-04.
Sponsored by Istituto Clinico Humanitas · Not applicable, Interventional, and Diagnostic
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 500 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
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Exclusion Criteria:
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.
Drug: Acetic Acid
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.
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.
Additional serrated lesions diagnosed after acetic acid spraying
Primary outcome is the additional number of serrated lesions detected at the level of the right colon after spraying of acetic acid and compared with the number of the same lesions detected after a second examination of the right colon using standard white-light high definition scopes
Time frame: 12 months
- Number of new adenoma detected at second right colon examination in both studies group
Time frame: 12 months
Number of overall serrated and/or adenomatous lesions in the whole colon
Time frame: 12 months
Characteristic of lesions detected (size, morphology)
Time frame: 12 months
Complication rate
Time frame: 12 months
This study is status unknown, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Istituto Clinico Humanitas