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Comparison between large volume and osmotic agent lavage for optimal colonoscopy bowel cleansing, randomizing adult outpatients by invitation letter
This randomized quality assurance trial aims to compare cleansing quality of two different principles of colonoscopy lavage. Large volume PEG solutions are considered safe, but cumbersome and inpalatable, while osmotic solutions are generally more acceptable, however, the risk of electrolyte disturbances or renal decompensation may increase.
The study will focus on patient experience and compliance, as well as cleansing quality, endoscopic findings and other technical parameters of the colonoscopy procedure that may be adversely affected by poor bowel cleansing. Three centers will participate, ensuring a diverse patient population. 800 patients are planned for recruitment, but an interim assessment of statistics of the primary aim parameter (bowel cleansing) will be performed to adjust the number.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| large volume | Active Comparator | bowel cleansing with PEG |
|
| Osmotic | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laxabon | Other | 4 l PEG solution split dose cleansing |
| |
| CitraFleet |
| Measure | Description | Time Frame |
|---|---|---|
| Bowel cleansing quality | 1 Day |
| Measure | Description | Time Frame |
|---|---|---|
| Colonoscopy findings | 1 Day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars Aabakken, prof of med | Prof of medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OUS Rikshospitalet, dept of med gastro | Oslo | Oslo | Norway | |||
| Sørlandet sykehus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26135098 | Derived | Leitao K, Grimstad T, Bretthauer M, Holme O, Paulsen V, Karlsen L, Isaksen K, Cvancarova M, Aabakken L. Polyethylene glycol vs sodium picosulfate/magnesium citrate for colonoscopy preparation. Endosc Int Open. 2014 Dec;2(4):E230-4. doi: 10.1055/s-0034-1377520. Epub 2014 Oct 24. |
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| Other |
Small volume osmotic bowelcleansing |
|
| Kristiansand |
| VestAgder |
| Norway |