Evaluating an oral solution for better colon cleansing
Evaluation of an Oral Sodium Sulfate Solution for Patients With Prior Difficult or Incomplete Cleansing, a Progressive Case Series.
This study is testing if a new oral solution can help people who had trouble with bowel prep before a colonoscopy to have a cleaner colon and better results.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Queen's University Academic / other |
| Locations | 2 sites (Kingston, Ontario and 1 other locations) |
| Trial ID | NCT06051955 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and tolerability of Oral Sodium Sulfate (OSS) in patients who have previously experienced poor bowel preparation for colonoscopy. Participants will receive OSS before their next surveillance colonoscopy, and their experiences will be assessed through questionnaires and patient diaries. The aim is to determine if OSS can improve colon cleansing outcomes compared to traditional agents, which can lead to better detection rates and fewer repeat procedures. OSS is a low-volume osmotic agent approved by health authorities for its efficacy and tolerability.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 who have a history of poor bowel preparation for colonoscopy.
Not a fit: Patients with inflammatory bowel disease, bowel obstruction, or other specified exclusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this could lead to improved colonoscopy preparation, enhancing detection rates of polyps and reducing the need for repeat procedures.
How similar studies have performed: Other studies have shown positive outcomes with similar osmotic agents for bowel preparation, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Kingston, Ontario and 1 other locations
- Hotel Dieu Hospital — Kingston, Ontario, Canada (Recruiting)
- Hotel Dieu Hospital — Kingston, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Lawrence Hookey — Queen's University
- Study coordinator: Jackie McKay
- Email: jackie.mckay@kingstonhsc.ca
- Phone: 613-544-3400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.