Colonoscopy Clinical Trial
— OSSOfficial title:
Evaluation of an Oral Sodium Sulfate Solution for Patients With Prior Difficult or Incomplete Cleansing, a Progressive Case Series.
This case series aims to evaluate the effectiveness and tolerability of Oral Sulfate Solution (OSS) in patients who had previously experienced poor colonoscopy preparation.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | September 30, 2024 |
Est. primary completion date | May 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Patients Age 18 to 80 inclusive 2. Able to read and understand the English language 3. History of poor bowel prep defined as: - Required extensive washing, as noted in the narrative of the endoscopist report. - Inadequate preparation - Endoscopist recommended shorter interval surveillance due to poor prep - adequate for polyps >5mm but not smaller lesions Exclusion Criteria: 1. Patients who have inflammatory bowel disease 2. Patients with ileus or bowel obstruction 3. Patients with history of colorectal resection 4. Patients receiving combined upper and lower endoscopies 5. Patients with ascites 6. Patients with previously documented severe renal impairment 7. Unable to provide consent 8. Pregnant or lactating female (females of child-bearing potential will undergo urine pregnancy testing) 9. Patients who have had a recent myocardial infarction(<6months) |
Country | Name | City | State |
---|---|---|---|
Canada | Hotel Dieu Hospital | Kingston | Ontario |
Canada | Hotel Dieu Hospital | Kingston | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lawrence Charles Hookey | Pendopharm |
Canada,
Anastassopoulos K, Farraye FA, Knight T, Colman S, Cleveland MV, Pelham RW. A Comparative Study of Treatment-Emergent Adverse Events Following Use of Common Bowel Preparations Among a Colonoscopy Screening Population: Results from a Post-Marketing Observational Study. Dig Dis Sci. 2016 Oct;61(10):2993-3006. doi: 10.1007/s10620-016-4214-2. Epub 2016 Jun 9. — View Citation
Hookey LC, Vanner S. A review of current issues underlying colon cleansing before colonoscopy. Can J Gastroenterol. 2007 Feb;21(2):105-11. doi: 10.1155/2007/634125. — View Citation
Johnson DA, Barkun AN, Cohen LB, Dominitz JA, Kaltenbach T, Martel M, Robertson DJ, Boland CR, Giardello FM, Lieberman DA, Levin TR, Rex DK; US Multi-Society Task Force on Colorectal Cancer. Optimizing adequacy of bowel cleansing for colonoscopy: recommendations from the US multi-society task force on colorectal cancer. Gastroenterology. 2014 Oct;147(4):903-24. doi: 10.1053/j.gastro.2014.07.002. No abstract available. — View Citation
Oldfield EC 4th, Johnson DA, Rex DK. Prescribing Colonoscopy Bowel Preparations: Tips for Maximizing Outcomes. Am J Gastroenterol. 2023 May 1;118(5):761-764. doi: 10.14309/ajg.0000000000002110. Epub 2022 Dec 26. No abstract available. — View Citation
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. — View Citation
Wang CN, Yang R, Hookey L. Does It work in Clinical Practice? A Comparison of Colonoscopy Cleansing Effectiveness in Clinical Practice Versus Efficacy from Selected Prospective Trials. J Can Assoc Gastroenterol. 2020 Jun;3(3):111-119. doi: 10.1093/jcag/gwy070. Epub 2019 Feb 12. — View Citation
Yang HJ, Park SK, Kim JH, Im JP, Yeom DH, Seo GS, Park DI. Randomized trial comparing oral sulfate solution with 4-L polyethylene glycol administered in a split dose as preparation for colonoscopy. J Gastroenterol Hepatol. 2017 Jan;32(1):12-18. doi: 10.1111/jgh.13477. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effectiveness | The primary outcome is proportion of patients with an adequate preparation (Boston preparation scale 6 or greater, with no section less than 2). | 1-2 days |
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