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

NARecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

April 10, 2025

Primary Completion Date

June 30, 2027

Study Completion Date

July 31, 2027

Conditions
Stoma - IleostomyHigh Output StomaColon CancerIBD (Inflammatory Bowel Disease)IleusOmeprazole
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.

Trial Locations (2)

80952

RECRUITING

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

81-519

RECRUITING

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

All Listed Sponsors
lead

Medical University of Gdansk

OTHER