Oral Sulfate Solution (SUPREP) Versus Polyethylene Glycol (PEG) Plus Ascorbic Acid
- Conditions
- Cathartic Colon
- Interventions
- Drug: 2-L PEG/Asc
- Registration Number
- NCT02761213
- Lead Sponsor
- Bo-In Lee
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- people who receive colonoscopy
- aged : 18-80
- people who sign the consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2-L PEG/Asc 2-L PEG/Asc low-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc) Oral sulfate solution (OSS) Oral sulfate solution (OSS) oral sulfate solution (OSS)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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.
Trial Locations
- Locations (1)
Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Seoul St. Mary's Hospital🇰🇷Seoul, Korea, Republic of