Effect of Rowachol on Prevention of Postcholecystectomy Syndrome

DongGuk University138 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

138

Conditions

Postcholecystectomy Syndrome

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 84 Years

Medical Language ↔ Plain English

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

Locations (2)

DongGuk University Ilsan Hospital

Goyang-si, Gyeonggi-do, South Korea

Chung-Ang University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

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.

Time frame: postoperative 3-month

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: postoperative 3-month