Effect of Rowachol on Prevention of Postcholecystectomy Syndrome

Study Overview
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Brief Summary
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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

Official Title
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Effect of Rowachol on Prevention of Postcholecystectomy Syndrome After Laparoscopic Cholecystectomy

Conditions
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Postcholecystectomy Syndrome

Intervention / Treatment
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* Drug: Rowachol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with pathologic diseases scheduled for laparoscopic cholecystectomy Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 84 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rowachol<br>Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months | Drug: Rowachol<br> <br> |
| Placebo Comparator: Placebo<br>Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Number of the Participants Have Postoperative RUQ Pain | 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. | postoperative 3-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory Test Results of Postoperative 3-month(Total Bilirubin, Direct Bilirubin) | laboratory test results(liver function test such as total bilirubin, direct bilirubin) measured at postoperative 3-month of Rowachol group and placebo group. each result is mean values. | postoperative 3-month | 
| Laboratory Test Results of Postoperative 3-month(Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase) | laboratory test results(liver function test such as Alkaline phosphatase, Aspartate aminotransferase, Alanine aminotransferase) measured at postoperative 3-month of Rowachol group and placebo group. each result is mean values. | postoperative 3-month | 
| Laboratory Test Results of Postoperative 3-month(WBC Count) | laboratory test results(WBC count) measured at postoperative 3-month of Rowachol group and placebo group. each result is mean values. | postoperative 3-month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postcholecystectomy syndrome, laparoscopic cholecystectomy, Rowachol