Prospective Study for the Effects of Biphenyl Dimethyl Dicarboxylate and Ursodeoxycolic Acid Therapy on Liver Function and Quality of Life After Laparoscopic Cholecystectomy
试验速览
- 阶段
- 3 期
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Serum Aspartate Aminotransferase
研究概览
简要总结
Prospective Study for the Effects of Biphenyl Dimethyl Dicarboxylate and Ursodeoxycolic Acid Therapy on Liver Function and Quality of Life After Laparoscopic Cholecystectomy
Primary endpoint: peak level of postoperative AST (aspartate transaminase) and postoperative ALT (alanine tansaminase)
Secondary endpoint: postoperative GIQLI (Gastrointestinal Quality of Life index) score
详细描述
Because the gallbladder is adjacent to the liver, liver enzymes are often elevated when cholecystitis occurs. BDD and UDCA drugs are known to be effective in preserving liver function. The use of BDD and UDCA drugs in patients with cholecystitis is expected to inhibit elevated liver enzyme levels and to maintain liver function. The aim of this study is to analyze the effects of BDD and UDCA medication on postoperative changes in hepatic enzyme levels and quality of life in patients LFT elevated cholecystitis.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Patients scheduled for surgery due to chronic cholecystitis and acute cholecystitis
排除标准
- •Failure to obtain consent
- •Under 19 years
- •If you have intellectual ability to understand this study
- •When performing cholecystectomy with other operations
- •Total bilirubin levels> 2 mg / dl
- •If you are enrolled in another clinical trial
研究组 & 干预措施
BDD with UDCA
Postoperative BDD with UDCA treatment
干预措施: BDD with UDCA (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Serum Aspartate Aminotransferase
时间窗: Postoperative 30 days
Serum aspartate aminotransferase level (U/ml) (continuous variable)
Serum Alanine Aminotransferase
时间窗: Postoperative 30 days
Serum Alanine Aminotransferase level (U/ml) (continuous variable)
次要结局
- GIQLI (Gastrointestinal Quality of Life Index)(Postoperative 30 days)
研究者
Huisong Lee
Assistant Professor
Ewha Womans University Mokdong Hospital