Plain English Summary
Background and study aims
Detection and removal of polyps during colonoscopy is crucial for the prevention of colorectal cancer. Acetic-acid spaying up to the colonic mucosa could probably increase the adenoma detection rate.
Who can participate?
All patients who are undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup.
What does the study involve?
Spraying acetic-acid during colonoscopy up to mucosa of the colon to increase polyp detection.
What are the possible benefits and risks of participating?
Increase polyp detection without any possible adverse events to have been reported from acetic-acid usage in the colon.
Where is the study run from?
From 2 general hospitals in Greece - Gastroenterology departments.
When is the study starting and how long is it expected to run for?
The study starts in July 2019 and lasts up to October 2019.
Who is funding the study?
General Hospital of Nikaia-Piraeus "Agios Panteleimon".
Who is the main contact?
Georgios Trimponias MD (diek@nikaia-hosp.gr)
Trial website
Contact information
Type
Scientific
Primary contact
Dr George Tribonias
ORCID ID
Contact details
D. Mantouvalou 3
Nikaia
Piraeus
Athens
Athens
18454
Greece
+302132077420
diek@nikaia-hosp.gr
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
AA1
Study information
Scientific title
Prospective randomized comparison of acetic-acid assisted colonoscopy versus standard wight-light colonoscopy in the detection of sessile serrated adenomatous (SSA) lesions in the right colon
Acronym
AA1
Study hypothesis
The purpose of this study is to compare the additional diagnostic yield obtained by using acetic acid as a vital substance to improve the detection of sessile serrated adenomatous (SSA) polyps in the right colon during a colonoscopy. lesions at colonoscopy.
Ethics approval
Approved 28/11/2018, the scientific-ethics board of the General Hospital of Nikaia-Piraeus "Agios Panteleimon" (D.Mantouvalou 3, Nikaia-Piraeus, Athens, 18454; epsymb@nikaia-hosp.gr; 00302132076235; 00302132077444), ref: 28/28-11-2018.
Study design
Multicentre interventional Prospective Randomized Trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Colorectal polyps detected by colonoscopy
Intervention
Patients who are scheduled for screening, surveillance or diagnostic colonoscopy will be recruited to the study and randomised 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 with high definition endoscope under white light. Once the right colon has been fully examined and all the detected polyps have been removed, the endoscopist will reach the cecum again and the patient will set in right lateral position . A solution with 250 cc normal saline and 25 cc acetic acid 2% will be used to fill in the right colon from the cecum to the hepatic flexure. The whole quantity of the solution will be inserted with the use of a water pump irrigator and all the air above the solution will be carefully suctioned in order for the largest surface of the mucosa to get in contact with the acetic acid solution. Afterwards, the patient will be positioned in the supine position for at least 30 seconds and then repositioned into the left lateral position. The endoscopist will suction as much as possible from the solution and then the second examination of the mucosa will start. Randomisation was done with SPSS program. There was not any treatment given to the patients. This study include only acetic acid spaying up to the colon mucosa for the detection of additional polyps.
Intervention type
Supplement
Phase
Drug names
Primary outcome measure
The additional number of sessile serrated adenomatous (SSA) 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 and solution without acetic acid.
Secondary outcome measures
Measured as numbers of the events and the polyps detected through the examinations:
1. Number of new serrated lesions detected at second right colon examination in both studies group.
2. Number of overall serrated and/or adenomatous lesions in the whole colon.
3. Characteristic of lesions detected (size, morphology).
4. Complication rate.
Overall trial start date
01/09/2018
Overall trial end date
01/10/2029
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. The patient is undergoing colonoscopy for screening, for surveillance in the follow-up of the previous polypectomy or for diagnostic workup.
2. The patient must understand and provide written consent for the procedure.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
400
Participant exclusion criteria
1. History of colonic resection.
2. Inflammatory bowel disease.
3. Personal history of a polyposis syndrome.
4. Suspected chronic stricture potentially precluding complete colonoscopy.
5. Diverticulitis or toxic megacolon.
6. History of radiation therapy to abdomen or pelvis.
7. Ulcer of the rectum.
8. Ischemic colitis or intestinal ischemia.
9. Inadequate bowel preparation (BBPS 3-6).
Recruitment start date
01/07/2019
Recruitment end date
01/10/2019
Locations
Countries of recruitment
Greece
Trial participating centre
General Hospital of Nikaia-Piraeus "Agios Panteleimon"
D. Mantouvalou, Nikaia, Piraeus, Athens, 18454
Athens
18454
Greece
Trial participating centre
Benizelion General hospital
Leoforos Knossou, Heraklion, Crete, Greece
Heraklion
71409
Greece
Sponsor information
Organisation
General Hospital of Nikaia-Piraeus "Agios Panteleimon"
Sponsor details
D. Mantouvalou 3
Nikaia
Piraeus
Athens
Athens
18454
Greece
+306977014305
epsymb@nikaia-hosp.gr
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
General Hospital of Nikaia-Piraeus
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Submitting in DDW 2020 and publishing in peer review journal in 2020.
IPD sharing statement: the datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
01/01/2020
Participant level data
Other
Basic results (scientific)
Publication list