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

NCT06917963 | Recruiting DMC

• 1 other identifier: KB/99/2025
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Keywords

stoma; ileostomy; high output stoma; omeprazole; ipp; colon cancer; ibd

Outcome Measures

Primary Outcomes (1)

• difference in mean ileostomy output (ml/24h) between postoperative days (POD) 1-3 between the experimental and control groups

  The primary endpoint is the difference in mean ileostomy output (ml/24h) between postoperative days (POD) 1-3 between the experimental and control groups, after excluding patients with minimal output (\<200 ml in any POD 1-3). A clinically significant reduction in output is defined as ≥250 ml/day.

  from stoma creation to postoperative day 3

Secondary Outcomes (4)

• Proportion of patients meeting the criteria for high-output stoma

  1 month from stoma creation

• Time to stabilization of ileostomy output

  1 month from stoma creation

• Incidence of dehydration-related complications

  30 days post discharge after stoma creation

• Total length of hospitalization

  30 days post discharge after stoma creation

Study Arms (2)

Intensified Treatment Arm

EXPERIMENTAL

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.

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

Standard Treatment Arm

ACTIVE COMPARATOR

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.

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

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.

Intensified Treatment Arm

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.

Standard Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (2)

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

Gdansk, Pomeranian Voivodeship, 80952, Poland

RECRUITING

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

Gdynia, 81-519, Poland

RECRUITING

Related Publications (4)

• Jeppesen 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 BACKGROUND

• Fujino 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 BACKGROUND

• Lederhuber 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 BACKGROUND

• Nightingale 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 BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms; Inflammatory Bowel Diseases; Ileus; Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Gastroenteritis; Intestinal Obstruction; Colonic Diseases, Functional

Study Officials

• Jarosław Kobiela, Professor

  MUG Division of General Surgery

  STUDY CHAIR

Central Study Contacts

Tomasz Sylwestrzak, MD

CONTACT

+48516077708; tomasz.sylwestrzak@gumed.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 9, 2025
• Study Start: April 10, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)