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Clinical trial evaluating efficacy of bowel cleansing solutions in patients with Inflammatory Bowel Disease.
Simple blind, randomized study evaluating efficacy of 1LPEG vs 2L PEG vs 2L sodium picosulfate in bowel cleansing of patients diagnosed of Inflammatory Bowel Disease undergoing diagnostic or follow-up routine colonoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1L PEG | Active Comparator |
| |
| 2L PEG | Active Comparator |
| |
| 2L sodium picosulfate | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopy | Procedure | Colonoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bowel cleansing | Boston Bowel Preparation Score (BBPS), a 10-point scale assessing bowel preparation after all cleansing maneuvers are completed by the endoscopist. Each region of the colon receives a "segment score" from 0 to 3 and these segment scores are summed for a total BBPS score ranging from 0 to 9. Therefore, the maximum BBPS score for a perfectly clean colon without any residual liquid is 9 and the minimum BBPS score for an unprepared colon is 0. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment related adverse events | Number of Participants with symptomatology related to intervention in each arm of the study | 1 year |
| Preparation Tolerability: total volume of solution finally taken by the patient |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Dolores Martin Arranz, PhD | Hospital Universitario La Paz. IdiPaz. Universidad Autónoma de Madrid. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario La Paz | Madrid | Madrd | 28046 | Spain |
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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 |
|---|---|
| D004724 | Endoscopy |
| ID | Term |
|---|---|
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
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Evaluation of total volume of solution finally taken by the patient
| 1 year |
| D013514 | Surgical Procedures, Operative |