Clinical trial NCT02231385: Acetic Acid Colonoscopy Enhancement Study
Official title: Acetic Acid Colonoscopy Enhancement Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Serrated Adenomas
Colon Nos Polypectomy Tubular Adenoma
Keywords: Colorectal cancer
Serrated adenomas
Screening
Adenoma detection rate
Polypectomy
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
Collaborators: name: Nuovo Regina Margherita Hospital
First posted: 2014-09-04
Enrollment: 500
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Additional serrated lesions diagnosed after acetic acid spraying
timeFrame: 12 months
Secondary outcomes:
measure: - Number of new adenoma detected at second right colon examination in both studies group
timeFrame: 12 months
measure: Number of overall serrated and/or adenomatous lesions in the whole colon
timeFrame: 12 months
measure: Characteristic of lesions detected (size, morphology)
timeFrame: 12 months
measure: Complication rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Nuovo Regina Margherita Hospital
city: Rozzano, Milan
country: Italy
facility: Humanitas Research Hospital
Study officials:
affiliation: Humanitas Research Hospital IRCCS, Rozzano-Milan
name: Alessandro Repici, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nuovo Regina Margherita Hospital
name: Cesare Hassan, MD
role: PRINCIPAL_INVESTIGATOR
References: