Tests higher-dose omeprazole to reduce high output from ileostomy
Tests intensified omeprazole against standard dosing in adults with ileostomy surgery.
Plain-language title generated from the registry record
Registry title: Study of Treatment With Intensified Omeprazole Treatment to Prevent High Output Stoma 1
Key facts
- Where
- Gdansk and Gdynia, PolandSee the 2 sites
Where in Poland
- Department of Oncological, Transplant and General Surgery, Univeristy Clinical CenterGdansk, PolandTaking people
- Clinical Department of Oncologic Surgery with a Subdivision of Breast, Skin, and Soft Tissue Tumor Surgery PCK Maritime HospitalGdynia, PolandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Medical University of Gdansk
- Trial code
- NCT06917963
- Record updated
- 31 July 2025
- Original description
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:Read full original descriptionShow less
Study of Treatment With Intensified Omeprazole Treatment to Prevent High Output Stoma 1: a Randomized, Non-blinded, Controlled Trial
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-discharge, and total length of hospital stay (including rehospitalizations).
Researchers will compare 10 days intensified omeprazole treatment (loading dose of 80 mg IV followed by 40 mg IV twice daily) with standard treatment (40 mg IV once daily) to determine the effectiveness of intensified dosing in reducing ileostomy output and improving postoperative outcomes.
Participants will:
* Receive either standard or intensified intravenous omeprazole during their hospitalization and after discharge for 10 days combined. * Undergo daily measurements of ileostomy output. * Have routine laboratory assessments of electrolyte levels. * Participate in follow-up assessments up to 30 days post-discharge, conducted either through outpatient visits or telephone consultations.
Inclusion: 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: Known hypersensitivity or allergy to proton pump inhibitors (including omeprazole); Conditions preventing accurate measurement of daily ileostomy output; Pregnancy or lactation.