Cathartic Colon
Conditions
Brief summary
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
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).
Interventions
Oral sulfate solution (OSS)
DRUG2-L PEG/Asc
Low-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc) COOLPREP is a proprietary name of 2-L PEG/Asc.
Sponsors
Pharmbio Korea Co., Ltd.
Bo-In Lee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Boston Bowel Preparation Scale (BPPS) | during colonoscopy | — |
| Aronchick scale | during colonoscopy | Aronchick scale is a commonly used bowel preparation scale to grade the adequacy of cleansing of colonic segments or the entire colon. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety by measuring hemodynamic and biochemical data | at baseline (in the clinic be- fore booking the colonoscopy) and on arrival at the en- doscopy suite | Biochemical data will be measured only in case of necessity such as weakness, mental change or numbness. |
| 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 | — |
| Tolerability by a patient questionnaire using 5-point Likert scale | on arrival at the endoscopy unit before colonoscopy | to assess tolerability of each bowel preparation |
Countries
South Korea
Outcome results
None listed