Study of Treatment With Intensified Omeprazole Treatment to Prevent High Output Stoma 1: a Randomized, Non-blinded, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- difference in mean ileostomy output (ml/24h) between postoperative days (POD) 1-3 between the experimental and control groups
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Pregnancy or lactation
- •Known hypersensitivity or allergy to proton pump inhibitors (including omeprazole)
- •Conditions preventing accurate measurement of daily ileostomy output
研究组 & 干预措施
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.
干预措施: Intensified intravenous omeprazole therapy (loading dose 80 mg IV, then 40 mg IV twice daily at 6:00 AM and 6:00 PM) (Drug)
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.
干预措施: Standard intravenous omeprazole therapy (40 mg IV once daily at 6:00 AM). (Drug)
结局指标
主要结局
difference in mean ileostomy output (ml/24h) between postoperative days (POD) 1-3 between the experimental and control groups
时间窗: from stoma creation to postoperative day 3
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.
次要结局
- Proportion of patients meeting the criteria for high-output stoma(1 month from stoma creation)
- Incidence of dehydration-related complications(30 days post discharge after stoma creation)
- Time to stabilization of ileostomy output(1 month from stoma creation)
- Total length of hospitalization(30 days post discharge after stoma creation)
研究者
Tomasz Sylwestrzak
Medical Doctor
Medical University of Gdansk