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Study of Treatment With Intensified Omeprazole Treatment to Prevent High Output Stoma 1

RecruitingNAAges 18 Years - anyAllMedical University of Gdansk
NCT06917963 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to evaluate if intensified omeprazole therapy can reduce high-output stoma (HOS) in adults undergoing ileostomy formation surgery. The main objectives of the study are: * To assess if intensified omeprazole treatment significantly reduces mean daily ileostomy output (ml/24h) during the first three postoperative days compared to standard omeprazole treatment. * To evaluate the proportion of patients meeting the criteria for high-output stoma (HOS ≥1400 ml/day) on consecutive postoperative days. * To measure the time required for stabilization of ileostomy output (\<1400 ml/day maintained for three consecutive days). * To determine the incidence of dehydration-related complications, specifically electrolyte disturbances (hyponatremia, hypokalemia). * To compare the length of initial hospital stay, frequency of rehospitalizations within 30 days post-disch

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📋 Eligibility rules (as published)
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
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What it tests

  • Intensified intravenous omeprazole therapy (loading dose 80 mg IV, then 40 mg IV twice daily at 6:00 AM and 6:00 PM)
  • Standard intravenous omeprazole therapy (40 mg IV once daily at 6:00 AM).
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Where

2 sites
Department of Oncological, Transplant and General Surgery, Univeristy Clinical Center
Gdansk, Poland
Clinical Department of Oncologic Surgery with a Subdivision of Breast, Skin, and Soft Tissue Tumor Surgery PCK Maritime Hospital
Gdynia, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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