Comparison of Two Methods of Bowel Preparation for Colonoscopy in Hospitalized Patients

Study Overview
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Brief Summary
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Morning-only colonoscopy preparation may improve efficiency by allowing same-day patient preparation and colonoscopy. The aim of the investigators study is to compare the efficacy and tolerability of morning-only Polyethylene Glycol (PEG) to split-dose preparation in hospitalized patients undergoing colonoscopy.

Detailed Description
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This is a single-center, prospective, endoscopist-blinded study in which hospitalized patients scheduled to undergo diagnostic colonoscopy were randomly assigned to receive one gallon of PEG either the morning of colonoscopy or as a split-dose (evening-morning). The primary end point is efficacy of colonoscopy preparation measured by the Ottawa scale. The investigators pre-specified a non-inferiority margin of 1.5 for the difference in Ottawa scale between arms. Secondary end points are patient compliance and tolerance. N: 120 hospitalized patients scheduled for diagnostic colonoscopy.

Official Title
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Comparison of Morning-only With Split-dose Polyethylene Glycol for Colonoscopy Preparation in Hospitalized Patients: A Randomized Controlled Non-Inferiority Study

Conditions
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Bowel Preparation for Colonoscopy

Intervention / Treatment
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* Other: Split-dose polyethylene glycol
* Other: Morning-only polyethylene glycol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients scheduled to undergo diagnostic colonoscopy during hospitalization Exclusion Criteria: Critically ill/Intensive Care Unit patients Suspected bowel obstruction/perforation History of colon resection Patients with altered mental status/inability to provide informed consent Incarcerated patients Pregnant females

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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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Morning-only polyethylene glycol<br>One gallon of polyethylene glycol to be taken between 5am and 9am on the day of colonoscopy. | Other: Morning-only polyethylene glycol<br>* One gallon of polyethylene glycol to be taken between 5am and 9am on the day of colonoscopy<br>|
| Active Comparator: Split-dose polyethylene glycol<br>Half gallon of polyethylene glycol to be taken between 7-9 pm on the day before colonoscopy and the remaining half between 7-9 am on the day of colonoscopy. | Other: Split-dose polyethylene glycol<br>* Half gallon of polyethylene glycol to be taken between 7-9 pm on the day before colonoscopy and the remaining half between 7-9 am on the day of colonoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the efficacy of colonoscopy preparation measured by the Ottawa scale | Colonoscopy was performed by gastroenterology fellows under the supervision of attending physicians and both were blinded to the type of preparation taken by the study patients. Bowel cleansing was evaluated by the Ottawa scale. Scoring of each part of the colon (right, middle and left) was done separately and the total amount of fluid was noted. The scores were then added to calculate the total score out of 14. | Day of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient compliance | Before the patients were taken to the endoscopy suite, they completed a questionnaire, asking the amount of preparation that was taken to evaluate compliance. | Day of procedure | 
| Patient tolerance | Before the patients were taken to the endoscopy suite, they completed a questionnaire to evaluate tolerance for taking the preparation. Patients were asked about side-effects like nausea, vomiting, abdominal pain and bloating. | Same day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy, bowel preparation, polyethylene glycol