Effect of Rowachol on Prevention of Postcholecystectomy Syndrome After Laparoscopic Cholecystectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 2
- 主要终点
- the Number of the Participants Have Postoperative RUQ Pain
研究概览
简要总结
Postcholecystectomy syndrome (PCS) includes a heterogeneous group of diseases, usually manifested by the presence of abdominal symptoms following gallbladder removal. The pathogenesis of PCS has not been identified; therefore there is no consensus of medical treatment on PCS. The Action of Rowachol are to inhibit hepatic 3-hydroxy-3-methylglutaric acid(HMG)-coenzyme A(CoA) reductase, to inhibits cholesterol nucleation in bile from patients with cholesterol gallstones, and to promote biliary lipid secretion.
The purpose of this study is to determine whether Rowachol is useful in the prevention of PCS and symptoms change after laparoscopic cholecystectomy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pathologic diseases scheduled for laparoscopic cholecystectomy
排除标准
- •Current immunosuppressive therapy
- •Chemotherapy within 4 weeks before operation
- •Radiotherapy completed longer than 4 weeks before operation
- •Inability to follow the instructions given by the investigator
- •Severe psychiatric or neurologic diseases
- •Drug- and/or alcohol-abuse according to local standards
- •Participation in another intervention-trial with interference of a primary or secondary endpoint of this study
- •Lack of compliance
- •Lack of informed consent
研究组 & 干预措施
Rowachol
Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months
干预措施: Rowachol (Drug)
Placebo
Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months
干预措施: Placebo (Drug)
结局指标
主要结局
the Number of the Participants Have Postoperative RUQ Pain
时间窗: postoperative 3-month
Right upper quadrant(RUQ) pain by European Organization for Research and Treatment of Cancer(EORTC) quality of life questionnaire(QLQ) C-30 No. 9, 19 at baseline and postoperative 3-month. The pain score of individuals at postoperative 3-month is calculated by EORTC QLQ C-30 manual. The pain score range is 0 to 100. Higher score means participants feel more pain(worse). If a participant's pain score is over 30, we define he/she has post operative RUQ pain. we use the number of the participants have post operative RUQ pain(score over 30) as the results.
次要结局
- Laboratory Test Results of Postoperative 3-month(Total Bilirubin, Direct Bilirubin)(postoperative 3-month)
- Laboratory Test Results of Postoperative 3-month(WBC Count)(postoperative 3-month)
- Laboratory Test Results of Postoperative 3-month(Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase)(postoperative 3-month)
研究者
In Woong Han
Assistant Professor
DongGuk University