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Comparison of two PEG-based bowel cleansing regimens in patients with inflammatory bowel disease.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 Liter PEG | Active Comparator | Colon preparation for colonoscopy: PEG 4 Liter before endoscopy |
|
| 2 Liter PEG plus bisacodil | Experimental | Colon preparation for colonoscopy: PEG 2 L before endoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colon preparation for colonoscopy | Drug | Colon cleansing prior to perform colonoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | Quality of colon cleansing assesse with Ottawa bowel preparation score | During endoscopy within 24 hours after preparation |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance | Intake of at least 75% of the product volume | during product assumption |
| Tollerability | Occurrence of discomfort during drug intake |
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Inclusion Criteria:
-Adult outpatiets with IBD colitis undergoing colonoscopy
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| gianpiero manes, MD | AO G. Salvini Garbagnate Milanes | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Luigi Sacco University Hospital | Milan | I-20157 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26164666 | Derived | Manes G, Fontana P, de Nucci G, Radaelli F, Hassan C, Ardizzone S. Colon Cleansing for Colonoscopy in Patients with Ulcerative Colitis: Efficacy and Acceptability of a 2-L PEG Plus Bisacodyl Versus 4-L PEG. Inflamm Bowel Dis. 2015 Sep;21(9):2137-44. doi: 10.1097/MIB.0000000000000463. |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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| during product assumption |
| safety | Occurrence of side effects | From drug intake to the end of colonoscopy |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |