Bowel Cleansing for Colonoscopy
Conditions
Keywords
colonoscopy, bowel cleansing
Brief summary
Comparison between large volume and osmotic agent lavage for optimal colonoscopy bowel cleansing, randomizing adult outpatients by invitation letter
Detailed description
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.
Interventions
OTHERCitraFleet
Small volume osmotic bowelcleansing
OTHERLaxabon
4 l PEG solution split dose cleansing
Sponsors
Helse Stavanger HF
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Pts for out-patient colonoscopy * age 18-80
Exclusion criteria
* Active colitis or suspicion thereof (bloody diarrhea, fever and abdominal pain) * Suspicion of renal insufficiency or ileus/subileus * Previous colonic surgery * Pregnancy * Inability to adhere to cleansing instructions * Inability to consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bowel cleansing quality | 1 Day |
Secondary
| Measure | Time frame |
|---|---|
| Colonoscopy findings | 1 Day |
Countries
Norway
Outcome results
None listed