Acetic Acid Colonoscopy Enhancement Study

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2015

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: 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.
  • No Intervention: Control Group
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Additional serrated lesions diagnosed after acetic acid spraying
    • Time Frame: 12 months
    • 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

Secondary Measures

  • – 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

Participating in This Clinical Trial

Inclusion Criteria

1. The patient is >40 years old 2. The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup; 3. The patient must understand and provide written consent for the procedure. Exclusion Criteria:

1. Patients with a history of colonic resection; 2. Patients with inflammatory bowel disease; 3. Patients with a personal history of polyposis syndrome; 4. Patients with suspected chronic stricture potentially precluding complete colonoscopy; 5. Patients with diverticulitis or toxic megacolon; 6. Patients with a history of radiation therapy to abdomen or pelvis; 7. Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Istituto Clinico Humanitas
  • Collaborator
    • Nuovo Regina Margherita Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Michele Tedeschi, MD – Istituto Clinico Humanitas
  • Overall Official(s)
    • Alessandro Repici, MD, Principal Investigator, Humanitas Research Hospital
    • Cesare Hassan, MD, Principal Investigator, Nuovo Regina Margherita Hospital
  • Overall Contact(s)
    • Alessandro Repici, MD, +390282247493, alessandro.repici@humanitas.it

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.