Protocol for Optimizing Colonoscopy Preparation in Patients With Inflammatory Bowel Disease

Study Overview
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Brief Summary
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Clinical trial evaluating efficacy of bowel cleansing solutions in patients with Inflammatory Bowel Disease.

Detailed Description
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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.

Official Title
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Protocol for Optimizing Colonoscopy Preparation in Patients With Inflammatory Bowel Disease

Conditions
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Inflammatory Bowel Diseases

Intervention / Treatment
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* Procedure: Endoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between 18y and 90y Patients with a diagnosis of IBD undergoing follow-up or screening colonoscopy Exclusion Criteria: Patients <18y or >90y Pregnant Women Patients with a past history of inadequate bowel cleansing in a colonoscopy performed in the previous 12 months prior to initiation of study Patients with a history of bowel resection Patients undergoing therapeutic colonoscopy Patients unable to understand study protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1L PEG<br> | Procedure: Endoscopy<br>* Colonoscopy<br>|
| Active Comparator: 2L PEG<br> | Procedure: Endoscopy<br>* Colonoscopy<br>|
| Active Comparator: 2L sodium picosulfate<br> | Procedure: Endoscopy<br>* Colonoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Evaluation of total volume of solution finally taken by the patient | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, Inflammatory Bowel Diseases