Multidisciplinary Approach Versus Conventional Approach in Colonic Preparation of Hospitalized Patients

Study Overview
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Brief Summary
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Colonoscopy is the gold standard diagnostic procedure for colonic disease. Excellent bowel cleansing is critical for this procedure. However, an inadequate bowel cleansing is a common problem that occurs up to 20% of procedures. This fact has a deep clinical and economical impact. In fact, inadequate bowel preparation is associated to misdiagnosis in 30% of lesions. Moreover several clinical conditions such as cirrhosis, antidepressant drugs, and hospitalized patients are predictive factors of inadequate colonic preparations. These circumstances have promoted multiple clinical trials, however there is no consensus about the optimal strategy for colonic cleansing. Education in colonic preparation has obtained conflicting results. Polyethylene glycol (PEG) and sodium phosphate solutions have been the commonest preparations used with a similar efficacy. However, the large volume to ingest (4 litters) makes PEG compliance difficult. Likewise, sodium phosphate also contains high levels in sodium and phosphate which contraindicate its use in elderly patients and / or with comorbidity. The use of adjuvants such as olive oil and bisacodyl allows reducing the volume of polyethylene glycol thereby improving the tolerance and right colon preparation. The aim of this study is to compare the efficacy of a multidisciplinary approach (education, fiber free diet, polyethylene glycol (PEG) 2L, and adjuvant bisacodyl + olive oil) vs. a conventional approach (fiber free diet+ PEG 4L in split doses ) in cleaning the colon of hospitalized patients.

Official Title
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Multidisciplinary Approach Versus Conventional Approach in Colonic Preparation of Hospitalized Patients. A Randomized Controlled Trial

Conditions
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Bowel Preparation for Colonoscopy

Intervention / Treatment
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* Behavioral: Education
* Other: Fiber free diet
* Dietary Supplement: Adjuvants
* Drug: Polyethylene glycol (PEG)
* Drug: Bisacodyl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalized patients who undergo a non urgent colonoscopy Patients who give informed consent to participate in the study Patients older than 18 years Patients who undergo total colonoscopy Exclusion Criteria: Non compliance with the 48 hours diet prescribed The endoscopy planned is a rectosigmoidoscopy Previous colonic surgery Mental/cognitive impairment preventing the study assessments Severe renal failure Electrolytic disbalance(hyponatremia, hypokaliemia, Hyperphosphatemia, hypocalcemia and hypomagnesemia) Intestinal obstruction, perforation or toxic megacolon Pregnant or nursing women Allergy/intolerance to PEG, bisacodyl or adjuvants No informed consent

Ages Eligible for Study
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Minimum Age: 18 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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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multidisciplinary approach<br>The multidisciplinary approach will include: Education Fiber free diet Bisacodyl: 10 mg 2 days before the procedure, 20 mg the day before the procedure and 10 mg 3 hours before the procedure Adjuvants: Olive Oil:60 mL/Apple Juice: 200 mL PEG: 1 L the night before the procedure and 1 L 3 hours before the procedure | Behavioral: Education<br> <br> Other: Fiber free diet<br> <br> Dietary Supplement: Adjuvants<br> <br> Drug: Polyethylene glycol (PEG)<br> <br> Drug: Bisacodyl<br> <br> |
| Active Comparator: Conventional approach<br>The conventional approach will include: Education Fiber free diet Polyethylene glycol (PEG): 2 L the night before the procedure, 2 L 3 hours before the procedure | Behavioral: Education<br> <br> Other: Fiber free diet<br> <br> Drug: Polyethylene glycol (PEG)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of patients with adequate bowel preparation | Adequate bowel preparation is defined as a preparation which allows exploring the whole colonic mucose and detecting flat lesions (Rating as good or excellent in the Boston Bowel preparation scale) | at the time of performing the colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with adequate bowel preparation by bowel segments | The boston scale will be assessed by the investigators during the procedure. | At the time of performing the colonoscopy | 
| Tolerance to the colonoscopy | Tolerance to the colonoscopy will be measured by VAS during the colonoscopy, 30 minutes after colonoscopy and 24 hours after colonoscopy | from colonoscopy up to 24 hours after colonoscopy | 
| Percentage of complete/incomplete colonoscopies and reprogramming | Evaluation of incomplete or inadequate bowel preparation will be assessed after performing the colonoscopy | After the colonoscopy | 
| Complications during and after the procedure |  | up to 24 hours after colonoscopy | 
| Doses of sedation needed during the colonoscopy | Final dose will be calculated at the end of the procedure | During the colonoscopy process | 
| Tolerance to the preparation |  | up to 48 hours | 
| Endoscopic findings |  | during the colonoscopy |