Oral Sulfate Solution (SUPREP) Versus Polyethylene Glycol (PEG) Plus Ascorbic Acid

Study Overview
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Brief Summary
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The aims of the present study is to compare oral sulfate solution (OSS) with low-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc) for bowel cleansing efficacy.

Detailed Description
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High-quality bowel cleansing is critical to effective colonoscopy. Studies in the past decade have demonstrated that many clinical practices continue to have rates of adequate preparation as low as 60% to 80%. Low-volume preparations for colonoscopy are designed to improve patient tolerability, another important aspect of bowel preparation. In addition, low-volume preparations should ideally not sacrifice efficacy. There are few data comparing the efficacy of available low-volume bowel preparations. In this study, we describe a prospective, single-blind, randomized, controlled trial comparing oral sulfate solution (OSS) (SUPREP, Braintree Laboratories, Braintree, Mass) with low-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc).

Official Title
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Efficacy of Reduced Volume Oral Sulfate Solution (SUPREP) Compared With PEG Plus Ascorbic Acid for Screening Colonoscopy: Single Center, Single Blinded Prospective Randomized Study

Conditions
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Cathartic Colon

Intervention / Treatment
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* Drug: Oral sulfate solution (OSS)
* Drug: 2-L PEG/Asc


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: people who receive colonoscopy aged : 18-80 people who sign the consent Exclusion Criteria: those aged over 80 years the disabled intestinal obstruction severe constipation previous history of bowel resection liver cirrhosis heart failure or ischemic heart disease within 6 months inflammatory bowel disease pregnant women severe renal insufficiency people who refuse to sign the consent

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral sulfate solution (OSS)<br>oral sulfate solution (OSS) | Drug: Oral sulfate solution (OSS)<br>* Oral sulfate solution (OSS)<br>* Other names: SUPREP;|
| Active Comparator: 2-L PEG/Asc<br>low-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc) | Drug: 2-L PEG/Asc<br>* Low-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc) COOLPREP is a proprietary name of 2-L PEG/Asc.<br>* Other names: COOLPREP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Boston Bowel Preparation Scale (BPPS) |  | during colonoscopy | 
| Aronchick scale | Aronchick scale is a commonly used bowel preparation scale to grade the adequacy of cleansing of colonic segments or the entire colon. | during colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability by a patient questionnaire using 5-point Likert scale | to assess tolerability of each bowel preparation | on arrival at the endoscopy unit before colonoscopy | 
| Safety by measuring hemodynamic and biochemical data | Biochemical data will be measured only in case of necessity such as weakness, mental change or numbness. | at baseline (in the clinic be- fore booking the colonoscopy) and on arrival at the en- doscopy suite | 
| Colonoscopic finding: whether there is erythematous mucosal change or apthous ulcers |  | during colonoscopy | 
| Percentage of cecal intubation |  | during colonoscopy | 
| Insertion time |  | during colonoscopy | 
| Withdrawal time |  | during colonoscopy | 
| Adenoma detection rate |  | during colonoscopy |