Condition category
Digestive System
Date applied
06/07/2019
Date assigned
21/09/2019
Last edited
21/08/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Publication citations

Additional files

Editorial Notes

21/08/2019: Trial's existence confirmed by the scientific-ethics board of the General Hospital of Nikaia-Piraeus "Agios Panteleimon".