Evaluation of an Oral Sodium Sulfate Solution for Patients With Prior Difficult or Incomplete Cleansing

NCT06051955 | Recruiting

• 1 other identifier: 6039506
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

This case series aims to evaluate the effectiveness and tolerability of Oral Sulfate Solution (OSS) in patients who had previously experienced poor colonoscopy preparation.

Conditions

Colonoscopy; Bowel Preparation

Keywords

Oral sodium sulfate

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

oral sodium sulfate

OTHER

OSS is a colon cleansing agent administered in a split dose fashion, inducing diarrhea by drawing water into the intestine.

Other: oral sodium sulfate

Interventions

oral sodium sulfate OTHER

All participants enrolled in this study will use Oral Sodium Sulfate as their bowel cleansing agent.

oral sodium sulfate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients Age 18 to 80 inclusive
• Able to read and understand the English language
• 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

You may not qualify if:

• Patients who have inflammatory bowel disease
• Patients with ileus or bowel obstruction
• Patients with history of colorectal resection
• Patients receiving combined upper and lower endoscopies
• Patients with ascites
• Patients with previously documented severe renal impairment
• Unable to provide consent
• Pregnant or lactating female (females of child-bearing potential will undergo urine pregnancy testing)
• Patients who have had a recent myocardial infarction(\<6months)

Sponsors & Collaborators

• Lawrence Charles Hookey: lead
• Pendopharm: collaborator

Study Sites (2)

Hotel Dieu Hospital

Kingston, Ontario, K7L 5G2, Canada

RECRUITING

Hotel Dieu Hospital

Kingston, Ontario, K7L5G2, Canada

RECRUITING

Related Publications (7)

• 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.

  PMID: 25239068 BACKGROUND

• 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.

  PMID: 36573902 BACKGROUND

• 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.

  PMID: 32395685 BACKGROUND

• 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.

  PMID: 17299615 BACKGROUND

• 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.

  PMID: 27278957 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.

  PMID: 25028274 BACKGROUND

• 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.

  PMID: 27349220 BACKGROUND

MeSH Terms

Interventions

sodium sulfate

Study Officials

• Lawrence Hookey

  Queen's University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jackie McKay

CONTACT

613-544-3400; jackie.mckay@kingstonhsc.ca

Rana Mohanna

CONTACT

613-544-3400; rana.mohanna@kingstonhsc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: This study will enroll participants who have experienced difficult or incomplete bowel cleansing in the past. All participants will use oral sodium sulfate as their cleansing agent.

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: September 25, 2023
• Study Start: October 11, 2023
• Primary Completion: May 30, 2024
• Study Completion: September 30, 2024
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)