Recruiting

Sodium Sulfate

Sponsor:

Lawrence Charles Hookey

Code:

NCT06051955

Conditions

Colonoscopy

Bowel Preparation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

oral sodium sulfate

Study Details

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

Study ID

NCT06051955

Start date

Oct 11, 2023

Status verified date

Apr, 2024

Completion date

Sep 30, 2024

Anticipated

Primary completion date

May 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

120 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: oral sodium sulfate

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

Interventions

oral sodium sulfate

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

Primary outcome measure

  • Effectiveness [ Time Frame: 1-2 days ]

Central Contacts and Locations

Locations

Hotel Dieu Hospital

Recruiting

Kingston, Ontario, Canada, K7L 5G2

Contacts

Principal Investigator:

Lawrence Hookey

Hotel Dieu Hospital

Recruiting

Kingston, Ontario, Canada, K7L5G2

Contacts

More Information

Sponsor

Lawrence Charles Hookey

Last update posted

Apr 3, 2024

Last verified

Apr, 2024

Keywords

  • Oral sodium sulfate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Lawrence Charles Hookey on 2024-04-03.