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RECRUITING
NCT06917963
NA

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

Sponsor: Medical University of Gdansk

View on ClinicalTrials.gov

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.

Official title: Study of Treatment With Intensified Omeprazole Treatment to Prevent High Output Stoma 1: a Randomized, Non-blinded, Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2025-04-10

Completion Date

2027-07

Last Updated

2025-07-31

Healthy Volunteers

No

Interventions

DRUG

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

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.

DRUG

Standard intravenous omeprazole therapy (40 mg IV once daily at 6:00 AM).

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.

Locations (2)

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

Gdansk, Pomeranian Voivodeship, Poland

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

Gdynia, Poland