NCT06917963 Study of Treatment With Intensified Omeprazole Treatment to Prevent High Output Stoma 1
| NCT ID | NCT06917963 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Gdansk |
| Condition | Stoma - Ileostomy |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-04-10 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2025-04-10 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Jarosław Kobiela, Professor
STUDY CHAIR
MUG Division of General Surgery
Frequently Asked Questions
Who can join the NCT06917963 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stoma - Ileostomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06917963 currently recruiting?
Yes, NCT06917963 is actively recruiting participants. Contact the research team at tomasz.sylwestrzak@gumed.edu.pl for enrollment information.
Where is the NCT06917963 trial being conducted?
This trial is being conducted at Gdansk, Poland, Gdynia, Poland.
Who is sponsoring the NCT06917963 clinical trial?
NCT06917963 is sponsored by Medical University of Gdansk. The principal investigator is Jarosław Kobiela, Professor at MUG Division of General Surgery. The trial plans to enroll 80 participants.