Evaluation of the Quality of Bowel Cleansing in a Real Clinical Practice Setting

Study Overview
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Brief Summary
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Publications of the use of bowel cleansers in usual clinical practice are lacking. Patient adherence to investigational products increases in the context of clinical trials. By the same token, efficacy of interventions may be overestimated in clinical trials. For this reason, an observational study to collect data on the effectiveness of several colonic preparations when these are used under usual clinical practice is proposed.

Official Title
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Evaluation of the Quality of Bowel Cleansing in a Real Clinical Practice Setting (CALICOL Study)

Conditions
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Bowel Preparation for Colonoscopy

Intervention / Treatment
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* Procedure: Bowel preparation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-80 years Subjects who have been performed a colonoscopy Exclusion Criteria: Subjects being previously performed colon surgery. Subjects suffering from active inflammatory bowel disease at the time of performing colonoscopy. Subjects with extreme limitations due to disease. Subjects in who Boston Bowel Preparation Scale (BBPS) is not available Subjects who have undergone a colonoscopy during their participation in another clinical study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Bowel preparation|Bowel preparation for bowel cleansing in a real clinical practice|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with adequate colon cleansing | Percentage of patients with punctuation in Boston bowel preparation scale (BBPS) ≥ 5 | Through study completion, an average of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with adequate colon cleansing of different administration schedules | Percentage of patients with punctuation in BBPS ≥ 5 in each administration schedule | Through study completion, an average of 6 months | 
| Identify factors influencing bowel cleansing quality | Relationship between BBPS ≥ 5 and age, gender, ethnicity, weight, height, tobacco consumption, concomitant diseases, medications and indication for colonoscopy in a multivariate analysis. | Through study completion, an average of 6 months | 
| Influence of total volume of liquid ingestion in the effectiveness of bowel cleansing agents | Relationship between BBPS ≥ 5and the volume of liquid ingestion | Through study completion, an average of 6 months | 
| Patients' tolerance | Percentage of each adverse event reported per patient in each administration schedule | Through study completion, an average of 6 months | 
| Quality of bowel cleansing comparison among different bowel cleansing agents | Comparison of percentage of patients with BBPS ≥ 5 between different bowel cleansing agents | Through study completion, an average of 6 months | 
| Subjects' satisfaction | Comparison of subjects' satisfaction between different bowel cleansing agents with a five point likert scale | Through study completion, an average of 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bowel cleansing, bowel preparation