Study of Treatment With Intensified Omeprazole Treatment to Prevent High Output Stoma 1 (STOP-HOS-1)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colon Cancer; Ileus; High Output Stoma; Omeprazole; IBD (Inflammatory Bowel Disease); Stoma - Ileostomy
• Intervention / Treatment: Drug: Standard intravenous omeprazole therapy (40 mg IV once daily at 6:00 AM).; Drug: Intensified intravenous omeprazole therapy (loading dose 80 mg IV, then 40 mg IV twice daily at 6:00 AM and 6:00 PM)

Detailed Description

This clinical trial investigates whether intensified omeprazole therapy can effectively reduce a condition known as high-output stoma (HOS) in adult patients undergoing ileostomy surgery. Ileostomy surgery involves creating an opening in the abdomen (stoma) to divert waste away from a diseased or surgically removed section of the intestine. After this procedure, some patients develop an excessive fluid output from the stoma, known as high-output stoma, defined as the production of more than 1400 ml of fluid per day. This excessive fluid loss can cause serious health issues, including severe dehydration, electrolyte imbalances (such as low sodium or potassium levels), nutritional deficiencies, increased risk of kidney problems, cardiovascular complications, and prolonged hospital stays.

Currently, the standard treatment for managing high-output stoma includes dietary changes, restricting fluid intake, administering anti-diarrheal medications like loperamide, and providing intravenous fluids and electrolytes. However, many patients continue to experience high stoma output despite these standard treatments.

Previous studies have suggested that proton pump inhibitors (PPIs) such as omeprazole, medications commonly used to reduce stomach acid, may help decrease the total amount of intestinal fluid produced. Omeprazole increases the pH level (reduces acidity) of the stomach contents, which might reduce irritation in the intestine and slow down fluid loss from the stoma. Although initial results are promising, current data are limited.

In this randomized clinical trial, researchers aim to determine if providing an intensified dosing regimen of omeprazole can significantly reduce ileostomy fluid output and improve clinical outcomes compared to the standard dosing. The study will include adult patients scheduled for elective or emergency ileostomy surgery.

Participants will be randomly assigned to one of two groups:

• Standard treatment group: Participants will receive the standard hospital treatment, which includes a daily intravenous dose of 40 mg omeprazole each morning.
• Intensified treatment group: Participants will receive an intensified regimen of omeprazole, starting with an initial intravenous loading dose of 80 mg, followed by 40 mg given twice daily (morning and evening) for 10 days.

The study's primary objective is to evaluate whether the intensified omeprazole treatment reduces the average daily ileostomy fluid output in the first three days after surgery. Additional objectives include assessing how quickly stoma output stabilizes (defined as output less than 1400 ml/day for three consecutive days), comparing the incidence of dehydration-related complications such as electrolyte imbalances, evaluating differences in hospital stay duration, and monitoring the rates of rehospitalization within 30 days after discharge.

Participants in both groups will undergo daily monitoring of their ileostomy output and regular blood tests to check electrolyte levels during their hospital stay. After discharge, participants will continue to be followed for 30 days through outpatient visits or telephone consultations to monitor any further complications or health issues.

The findings of this study could provide crucial evidence regarding the benefits of intensified omeprazole therapy. If proven effective, this approach may significantly improve patient outcomes, reduce the frequency of complications associated with high-output stomas, shorten hospital stays, and lower healthcare costs related to postoperative care.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tomasz Sylwestrzak, MD; Phone Number: +48516077708; Email: tomasz.sylwestrzak@gumed.edu.pl

Study Locations

• Poland
  • Gdynia, Poland, 81-519
    • Recruiting
    • Clinical Department of Oncologic Surgery with a Subdivision of Breast, Skin, and Soft Tissue Tumor Surgery PCK Maritime Hospital
    • Contact: Katarzyna Suwała, MD; Phone Number: 0048 513359794; Email: ksuwala8@gmail.com
    • Principal Investigator: Katarzyna Suwała, MD
  • Pomerania
    • Gdansk, Pomerania, Poland, 80952
      • Recruiting
      • Department of Oncological, Transplant and General Surgery, Univeristy Clinical Center
      • Contact: Tomasz Sylwestrzak, MD; Phone Number: +48 516077708; Email: tomasz.sylwestrzak@gumed.edu.pl
      • Contact: Piotr Spychalski, PhD; Phone Number: +48667843555; Email: piotr.spychalski@gumed.edu.pl
      • Principal Investigator: Tomasz Sylwestrzak, MD
      • Principal Investigator: Piotr Spychalski, PhD
      • Principal Investigator: Michalina Ciosek, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients meeting the criteria for high-output stoma	Proportion of patients meeting the criteria for high-output stoma (HOS ≥1400 ml/day) on consecutive postoperative days.	1 month from stoma creation
Time to stabilization of ileostomy output	Time to stabilization of ileostomy output (defined as output consistently <1400 ml/day for three consecutive days).	1 month from stoma creation
Incidence of dehydration-related complications	Incidence of dehydration-related complications (hyponatremia, hypokalemia). Hyponatremia will be evaluated by the number of hyponatremia incidents during the hospitalization and 30 days after discharge. Hypokalemia will be evaluated by the total sum of supplementation (g) needed and the number of hypokalemia incidents during the hspitalization.	30 days post discharge after stoma creation
Total length of hospitalization	Length of initial hospital stay (LOS - length of stay), rehospitalization rate within 30 days post-discharge, and total length of hospitalization (TLOS - total length of stay).	30 days post discharge after stoma creation

Collaborators and Investigators

• Sponsor: Medical University of Gdansk
• Investigators: Study Chair: Jarosław Kobiela, Professor, MUG Division of General Surgery

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: March 27, 2025
• First Submitted That Met QC Criteria: April 5, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): July 31, 2025
• Last Update Submitted That Met QC Criteria: July 28, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: ileostomy; colon cancer; omeprazole; stoma; ibd; high output stoma; ipp
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Gastroenteritis; Colonic Neoplasms; Inflammatory Bowel Diseases; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Enzyme Inhibitors; Anti-Ulcer Agents; Proton Pump Inhibitors; Omeprazole
• Other Study ID Numbers: KB/99/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No