Clinical Trial: Effect of Rowachol on Prevention of Postcholecystectomy Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

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


Detailed Summary:
Sponsor: DongGuk University

Current Primary Outcome: the Number of the Participants Have Postoperative RUQ Pain [ Time Frame: 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.



Original Primary Outcome: Right upper quadrant(RUQ) pain score [ Time Frame: baseline and postoperative 3 months after ]

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 months after.

The difference of Pain score from 3months to baseline will be calculated by EORTC QLQ C-30 manual.



Current Secondary Outcome:

  • Laboratory Test Results of Postoperative 3-month(Total Bilirubin, Direct Bilirubin) [ Time Frame: postoperative 3-month ]

    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.

  • Laboratory Test Results of Postoperative 3-month(Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase) [ Time Frame: postoperative 3-month ]

    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.

  • Laboratory Test Results of Postoperative 3-month(WBC Count) [ Time Frame: postoperative 3-month ]

    laboratory test results(WBC count) measured at postoperative 3-month of Rowachol group and placebo group.

    each result is mean values.



Original Secondary Outcome: Changing pattern of liver function test [ Time Frame: baseline and postoperative 3 months after ]

3 months minus baseline


Information By: DongGuk University

Dates:
Date Received: January 7, 2013
Date Started: January 2013
Date Completion:
Last Updated: November 16, 2014
Last Verified: November 2014