Luigi Sacco University Hospital
Milan, I-20157, Italy
NCT Number: NCT02248337
Comparison of two PEG-based bowel cleansing regimens in patients with inflammatory bowel disease.
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Notify Me18 year–85 year
Interventional
Phase 4
Milan, I-20157, Italy
Low-volume preparations are gaining attention for higher acceptability. This study compares efficacy, safety and tolerability of a 2L PEG solution plus bisacodil with a 4L PEG solution in patients with inflammatory bowel disease-related colitis.
This will be a multicenter, randomized, single-blind study. Adult outpatients with IBD colitis undergoing colonoscopy will receive either 2L PEG plus biscodil or 4L PEG. Bowel cleansing will be assessed using the Ottawa Scale and rated as adequate if <6. Patient acceptance, satisfaction, and related symptoms will be also recorded. The study will also focus on the factors affecting quality of preparation in inflammatory bowel disease patients such as disease characteristics and administration regimen
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-Adult outpatiets with IBD colitis undergoing colonoscopy
Exclusion criteria
Colon cleansing prior to perform colonoscopy
Other names: Colon cleansing
Time frame: During endoscopy within 24 hours after preparation
Quality of colon cleansing assesse with Ottawa bowel preparation score
Time frame: during product assumption
Intake of at least 75% of the product volume
Time frame: during product assumption
Occurrence of discomfort during drug intake
Time frame: From drug intake to the end of colonoscopy
Occurrence of side effects
Luigi Sacco University Hospital
Other
Colon Cleasing for Colonoscopy in Patients With IBD Colitis: Efficacy and Acceptability of 4 Liter PEG vs 2 Liter PEG Plus Bisacodil
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