Intensified omeprazole treatment to reduce high-output stoma in ileostomy patients
Study of Treatment With Intensified Omeprazole Treatment to Prevent High Output Stoma 1: a Randomized, Non-blinded, Controlled Trial
This study tests if a stronger dose of omeprazole can help adults with ileostomy surgery have less stoma output and stay out of the hospital longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Gdansk Academic / other |
| Locations | 2 sites (Gdansk, Pomeranian Voivodeship and 1 other locations) |
| Trial ID | NCT06917963 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of intensified omeprazole therapy in reducing high-output stoma (HOS) in adults undergoing ileostomy surgery. The study compares the mean daily ileostomy output between patients receiving intensified omeprazole treatment and those on standard therapy during the first three postoperative days. It also assesses the incidence of dehydration-related complications and the overall length of hospital stay. By investigating the potential benefits of omeprazole in managing excessive stoma output, the trial aims to improve patient outcomes following ileostomy procedures.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years or older scheduled for ileostomy formation surgery.
Not a fit: Patients who are pregnant, lactating, or have known allergies to proton pump inhibitors will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce fluid loss and related complications for patients with high-output stomas.
How similar studies have performed: Previous studies have suggested that proton pump inhibitors like omeprazole may effectively reduce intestinal fluid production, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 years or older * Scheduled for elective or emergency surgery requiring end or loop ileostomy formation * Able and willing to provide written informed consent * No contraindications to omeprazole use Exclusion Criteria: * Pregnancy or lactation * Known hypersensitivity or allergy to proton pump inhibitors (including omeprazole) * Conditions preventing accurate measurement of daily ileostomy output
Where this trial is running
Gdansk, Pomeranian Voivodeship and 1 other locations
- Department of Oncological, Transplant and General Surgery, Univeristy Clinical Center — Gdansk, Pomeranian Voivodeship, Poland (Recruiting)
- Clinical Department of Oncologic Surgery with a Subdivision of Breast, Skin, and Soft Tissue Tumor Surgery PCK Maritime Hospital — Gdynia, Poland (Recruiting)
Study contacts
- Study coordinator: Tomasz Sylwestrzak, MD
- Email: tomasz.sylwestrzak@gumed.edu.pl
- Phone: +48516077708
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.