Loperamide vs. Placebo's Effect on Ileostomy Output: A Clinical Randomized Blinded Cross-over Study
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Output weight
研究概览
简要总结
Clinical experience show limited effect of the drug Loperamide used to decrease output in stoma patients. Therefore the investigators see the need for a randomized blinded clinical trial to determine the effect of Loperamide opposite Placebo.
Loperamide will be evaluated in relation to the following parameters
- Change in ileostomy output in g/day in relation to oral intake
- Quantification of the change in intestinal transit time using a radiopaque marker
- The patient´s own assessment on which period they received Loperamide or Placebo
详细描述
The aim of this study is to quantify the effect of Loperamide on ileostomy output in patients operated for rectal cancer, ulcerative colitis and in patients with short bowl syndrome. These patients are recruited through The Department of Surgery and The Department of Gastroenterology, University Hospital Odense. The effect of Loperamide will be evaluated against Placebo in relation to the following parameters:
- Change in ileostomy output in g/day in relation to oral intake
- Quantification of the change in intestinal transit time using a radiopaque marker
- The patient´s own assessment on which period they received Loperamide or Placebo
Construction of a stoma is a frequently used part of the surgical treatment of intestinal cancer and chronic intestinal inflammation. More than 60% of patients with an ileostomy develop dehydration and loss of salts and minerals, due to an excessive stoma output. The most common method used to reduce stoma output is Imodium® ( Loperamide ). The effect has never been studied extensively, probably because it is an over the counter medicine. The treatment is relatively expensive and also subject to side effects, even if they are mild. Therefore, the investigators found it relevant to perform a clinical study to determine the effect. The results will be important for future patient treatment.
The study is a clinical blinded randomized crossover study. The study includes three types of patients. Patients operated for rectal cancer or ulcerative colitis with a temporary or permanent ileostomy, and patients with short bowel syndrome with a permanent ileostomy. The first two types of patients will be recruited through two ways.
- During hospitalization in connection to their operation at The Department of Surgery, University Hospital Odense. The patients are offered inclusion into the study either before or after surgery depending upon the clinical situation. For those who consent and fulfills the inclusion criteria, the study starts up on 7th day after surgery.
- Through their regular controls in the stoma clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Operation for rectal cancer or ulcerative colitis an ileostomy (loop or end ileostomy within the last 7 days) OR
- •ileostomy patient with contact to the stoma clinic OR
- •Short bowel syndrome with a permanent ileostomy
- •signed consent form
排除标准
- •Complications associated with surgery
- •Non-radical surgery
- •Chemotherapy
- •Poor compliance
- •Other serious illness
研究组 & 干预措施
Placebo
Patients will take the drug for three days. Day 1 - uploading with the drug Day 2 - collecting output when necessary Day 3 - radiopaque marker and collection of output every two hours
干预措施: Placebo (Drug)
Loperamide
Patients will take the drug for three days. Day 1 - uploading with the drug Day 2 - collecting output when necessary Day 3 - radiopaque marker and collection of output every two hours
干预措施: Loperamide (Drug)
结局指标
主要结局
Output weight
时间窗: 2 days
Collection af output for two days to compare between the two periods
次要结局
- Gastrointestinal transit time(10 hours)
研究者
Niels Qvist
Professor
Odense University Hospital