Acetic-acid enhanced colonoscopy for the increase of polyp detection
| ISRCTN | ISRCTN78002736 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78002736 |
| Secondary identifying numbers | AA1 |
- Submission date
- 06/07/2019
- Registration date
- 21/09/2019
- Last edited
- 21/08/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Digestive System
Plain English summary of protocol
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)
Contact information
Scientific
D. Mantouvalou 3
Nikaia
Piraeus
Athens
Athens
18454
Greece
| Phone | +302132077420 |
|---|---|
| diek@nikaia-hosp.gr |
Study information
| Study design | Multicentre interventional Prospective Randomized Trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| 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 |
| Study acronym | AA1 |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/09/2018 |
| Completion date | 01/10/2029 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 400 |
| Key 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. |
| Key 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). |
| Date of first enrolment | 01/07/2019 |
| Date of final enrolment | 01/10/2019 |
Locations
Countries of recruitment
- Greece
Study participating centres
Athens
18454
Greece
Heraklion
71409
Greece
Sponsor information
Hospital/treatment centre
D. Mantouvalou 3
Nikaia
Piraeus
Athens
Athens
18454
Greece
| Phone | +306977014305 |
|---|---|
| epsymb@nikaia-hosp.gr |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/01/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Submitting in DDW 2020 and publishing in peer review journal in 2020. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Editorial Notes
21/08/2019: Trial's existence confirmed by the scientific-ethics board of the General Hospital of Nikaia-Piraeus "Agios Panteleimon".
