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| Name | Class |
|---|---|
| Pharmbio Korea Co., Ltd. | INDUSTRY |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral sulfate solution (OSS) | Experimental | oral sulfate solution (OSS) |
|
| 2-L PEG/Asc | Active Comparator | low-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral sulfate solution (OSS) | Drug | Oral sulfate solution (OSS) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bo-In Lee, MD, PhD | Seoul St. Mary's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul St. Mary's Hospital | Seoul | 137-040 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16635231 | Background | Rex DK, Petrini JL, Baron TH, Chak A, Cohen J, Deal SE, Hoffman B, Jacobson BC, Mergener K, Petersen BT, Safdi MA, Faigel DO, Pike IM; ASGE/ACG Taskforce on Quality in Endoscopy. Quality indicators for colonoscopy. Am J Gastroenterol. 2006 Apr;101(4):873-85. doi: 10.1111/j.1572-0241.2006.00673.x. No abstract available. | |
| 24965898 |
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| 2-L PEG/Asc | Drug | Low-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc) COOLPREP is a proprietary name of 2-L PEG/Asc. |
|
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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 |
| Bannas P, Bakke J, Patrick JL, Pickhardt PJ. Automated volumetric analysis for comparison of oral sulfate solution (SUPREP) with established cathartic agents at CT colonography. Abdom Imaging. 2015 Jan;40(1):11-8. doi: 10.1007/s00261-014-0186-x. |
| 25028274 | Background | Rex DK, DiPalma JA, McGowan J, Cleveland Mv. A comparison of oral sulfate solution with sodium picosulfate: magnesium citrate in split doses as bowel preparation for colonoscopy. Gastrointest Endosc. 2014 Dec;80(6):1113-23. doi: 10.1016/j.gie.2014.05.329. Epub 2014 Jul 12. |
| 30308546 | Derived | Lee HH, Lim CH, Kim JS, Cho YK, Lee BI, Cho YS, Lee IS, Choi MG. Comparison Between an Oral Sulfate Solution and a 2 L of Polyethylene Glycol/Ascorbic Acid as a Split Dose Bowel Preparation for Colonoscopy. J Clin Gastroenterol. 2019 Nov/Dec;53(10):e431-e437. doi: 10.1097/MCG.0000000000001137. |