Clinical trial · Interventional
Study of Treatment With Intensified Omeprazole Treatment to Prevent High Output Stoma 1
Study of Treatment With Intensified Omeprazole Treatment to Prevent High Output Stoma 1: a Randomized, Non-blinded, Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| High Output Stoma | — | UNRESOLVED | — |
| IBD (Inflammatory Bowel Disease) | — | UNRESOLVED | — |
| Ileus | — | UNRESOLVED | — |
| Omeprazole | — | UNRESOLVED | — |
| Stoma - Ileostomy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intensified intravenous omeprazole therapy (loading dose 80 mg IV, then 40 mg IV twice daily at 6:00 AM and 6:00 PM) | Drug | — | UNRESOLVED |
| Standard intravenous omeprazole therapy (40 mg IV once daily at 6:00 AM). | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intensified Treatment Arm
- description
- 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.
- interventionNames
- Drug: Intensified intravenous omeprazole therapy (loading dose 80 mg IV, then 40 mg IV twice daily at 6:00 AM and 6:00 PM)
- type
- ACTIVE_COMPARATOR
- label
- Standard Treatment Arm
- description
- 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.
- interventionNames
- Drug: Standard intravenous omeprazole therapy (40 mg IV once daily at 6:00 AM).
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDJeppesen PB, Staun M, Tjellesen L, Mortensen PB. Effect of intravenous ranitidine and omeprazole on intestinal absorption of water, sodium, and macronutrients in patients with intestinal resection. Gut. 1998 Dec;43(6):763-9. doi: 10.1136/gut.43.6.763. PMID 9824602
- BACKGROUNDFujino S, Miyoshi N, Ohue M, Takahashi Y, Yasui M, Sugimura K, Akita H, Takahashi H, Kobayashi S, Yano M, Sakon M. Prediction model and treatment of high-output ileostomy in colorectal cancer surgery. Mol Clin Oncol. 2017 Sep;7(3):468-472. doi: 10.3892/mco.2017.1336. Epub 2017 Jul 19. PMID 28894582
- BACKGROUNDLederhuber H, Massey LH, Kantola VE, Siddiqui MRS, Sayers AE, McDermott FD, Daniels IR, Smart NJ. Clinical management of high-output stoma: a systematic literature review and meta-analysis. Tech Coloproctol. 2023 Dec;27(12):1139-1154. doi: 10.1007/s10151-023-02830-1. Epub 2023 Jun 18. PMID 37330988
- BACKGROUNDNightingale J, Woodward JM; Small Bowel and Nutrition Committee of the British Society of Gastroenterology. Guidelines for management of patients with a short bowel. Gut. 2006 Aug;55 Suppl 4(Suppl 4):iv1-12. doi: 10.1136/gut.2006.091108. No abstract available. PMID 16837533