Acetic Acid Colonoscopy Enhancement Study

Not Applicable

• Conditions: Colorectal Cancer; Serrated Adenomas; Colon Nos Polypectomy Tubular Adenoma
• Interventions: Drug: Acetic Acid

• Registration Number: NCT02231385
• Lead Sponsor: Istituto Clinico Humanitas

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

Not available

Study Timeline

• Status Verified: 2014-09
• Study Start: 2014-09
• Study First Submitted: 2014-09-01
• Study First Submitted QC: 2014-09-01
• Last Update Submitted: 2014-09-01
• Study First Posted: 2014-09-04
• Last Update Posted: 2014-09-04
• Primary Completion: 2015-01
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acetic Acid	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.

Primary Outcome Measures

Name	Time	Method
Additional serrated lesions diagnosed after acetic acid spraying	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 Outcome Measures

Name	Time	Method
Complication rate	12 months
- Number of new adenoma detected at second right colon examination in both studies group	12 months
Number of overall serrated and/or adenomatous lesions in the whole colon	12 months
Characteristic of lesions detected (size, morphology)	12 months

Trial Locations

Locations (2)

Nuovo Regina Margherita Hospital; 🇮🇹 Rome, Italy

Humanitas Research Hospital; 🇮🇹 Rozzano, Milan, Italy