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

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

Detailed Description
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This study aims to evaluate the effectiveness of Oral Sodium Sulfate (OSS) in patients who have had poor colon preparation in the past. The study includes patients who had issues during their previous colonoscopy, such as needing extensive washing, inadequate preparation, a recommendation for shorter surveillance intervals, or adequate preparation for larger polyps but not smaller lesions. Poor colon cleansing during a colonoscopy can lead to more prolonged procedures, lower polyp detection rates, and the need for repeat procedures with shorter surveillance intervals. OSS is a low-volume osmotic agent that causes diarrhea and colon cleansing by drawing water into the intestine. Health Canada and the FDA have approved it, and it is given in two 177ml bottles in a split dose. OSS is known for its good effect, ease of use, and tolerability, and it may be a better option than traditional cleansing agents. All participants will receive OSS and instructions for use before their next surveillance colonoscopy. The study will use questionnaires and patient diaries to assess the effectiveness of OSS and patient compliance and tolerability.

Official Title
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Evaluation of an Oral Sodium Sulfate Solution for Patients With Prior Difficult or Incomplete Cleansing, a Progressive Case Series.

Conditions
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Colonoscopy, Bowel Preparation

Intervention / Treatment
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* Other: oral sodium sulfate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: oral sodium sulfate<br>OSS is a colon cleansing agent administered in a split dose fashion, inducing diarrhea by drawing water into the intestine. | Other: oral sodium sulfate<br>* All participants enrolled in this study will use Oral Sodium Sulfate as their bowel cleansing agent.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral sodium sulfate