Low Volume Colon Preparation for IBD

Study Overview
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Brief Summary
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Comparison of two PEG-based bowel cleansing regimens in patients with inflammatory bowel disease.

Detailed Description
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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

Official Title
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Colon Cleasing for Colonoscopy in Patients With IBD Colitis: Efficacy and Acceptability of 4 Liter PEG vs 2 Liter PEG Plus Bisacodil

Conditions
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Inflammatory Bowel Disease

Intervention / Treatment
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* Drug: Colon preparation for colonoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Adult outpatiets with IBD colitis undergoing colonoscopy Exclusion Criteria: Previous colon resection, ileus, intestinal obstruction, toxic megacolon, severe heart failure (NYHA Class III or IV), acute cardiovascular disease, uncontrolled arterial hypertension (systolic pressure >170 mmHg, diastolic pressure >100 mmHg), severe liver cirrhosis (Child-Pugh score C) or renal failure (creatinine clearance<30 mL/minute), ascites, phenylketonuria, and glucose-6-phosphate dehydrogenase deficiency Pregnant or breastfeeding women were also excluded

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years


Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 4 Liter PEG<br>Colon preparation for colonoscopy: PEG 4 Liter before endoscopy | Drug: Colon preparation for colonoscopy<br>* Colon cleansing prior to perform colonoscopy<br>* Other names: Colon cleansing;|
| Experimental: 2 Liter PEG plus bisacodil<br>Colon preparation for colonoscopy: PEG 2 L before endoscopy | Drug: Colon preparation for colonoscopy<br>* Colon cleansing prior to perform colonoscopy<br>* Other names: Colon cleansing;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Quality of colon cleansing assesse with Ottawa bowel preparation score | During endoscopy within 24 hours after preparation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance | Intake of at least 75% of the product volume | during product assumption | 
| Tollerability | Occurrence of discomfort during drug intake | during product assumption | 
| safety | Occurrence of side effects | From drug intake to the end of colonoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colon preparation; Colonoscopy; Inflammatory bowel disease