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

Sponsor
Medical University of Gdansk
Study ID
NCT06917963
Status
Recruiting
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Conditions

  • Colon Cancer
  • High Output Stoma
  • IBD (Inflammatory Bowel Disease)
  • Ileus
  • Omeprazole
  • Stoma - Ileostomy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intensified intravenous omeprazole therapy (loading dose 80 mg IV, then 40 mg IV twice daily at 6:00 AM and 6:00 PM) — DRUG
    This intervention consists of intensified intravenous omeprazole therapy specifically designed to reduce high-output ileostomy after surgery. It includes an initial loading dose of 80 mg omeprazole administered intravenously on the day before surgery (or on the day of surgery in emergency cases), followed by a continuous treatment of 40 mg intravenously twice daily (at 6:00 AM and 6:00 PM) during hospitalization and after discharge to complete 10 day therapy, distinguishing it from standard once-daily omeprazole dosing protocols typically used for gastrointestinal ulcer prophylaxis.
  • Standard intravenous omeprazole therapy (40 mg IV once daily at 6:00 AM). — DRUG
    The control group will receive standard intravenous omeprazole therapy as per routine clinical practice for gastrointestinal prophylaxis. Participants will receive a single daily dose of 40 mg omeprazole intravenously administered at 6:00 AM during hospitalization. This standard dosing regimen serves as the comparator for assessing the efficacy of the intensified dosing regimen used in the experimental group.

Study Details

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.

Key Dates

First listed
Apr 9, 2025
Start date
Apr 10, 2025
Status verified
Jul 2025
Primary completion
Jun 30, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intensified Treatment Arm
    Participants in this group will receive intensified therapy, starting with an initial intravenous loading dose of 80 mg of omeprazole, followed by 40 mg administered intravenously twice daily (morning and evening) during hospitalization and after discharge to complete 10 days of omeprazole therapy.
  • Active Comparator: Standard Treatment Arm
    Participants in this group will receive the standard therapy consisting of a single daily intravenous dose of omeprazole (40 mg), administered each morning during hospitalization.

Primary Outcome Measure

difference in mean ileostomy output (ml/24h) between postoperative days (POD) 1-3 between the experimental and control groups [ Time Frame: from stoma creation to postoperative day 3 ]

Central Contacts

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