Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06917963

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

Led by Medical University of Gdansk · Updated on 2025-07-31

80

Participants Needed

2

Research Sites

116 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Pregnancy or lactation
  • Known hypersensitivity or allergy to proton pump inhibitors (including omeprazole)
  • Conditions preventing accurate measurement of daily ileostomy output

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Department of Oncological, Transplant and General Surgery, Univeristy Clinical Center

Gdansk, Pomeranian Voivodeship, Poland, 80952

Actively Recruiting

2

Clinical Department of Oncologic Surgery with a Subdivision of Breast, Skin, and Soft Tissue Tumor Surgery PCK Maritime Hospital

Gdynia, Poland, 81-519

Actively Recruiting

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Research Team

T

Tomasz Sylwestrzak, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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