Effect of Rowachol on Prevention of Postcholecystectomy Syndrome

Postcholecystectomy Syndrome Clinical Trial

Official title:

Effect of Rowachol on Prevention of Postcholecystectomy Syndrome After Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01765465
• Other study ID #: S-2012-E0816-00001
• Status: Completed
• Phase: Phase 4
• First received: January 7, 2013
• Last updated: November 16, 2014
• Start date: January 2013
• Est. completion date: July 2014

Study information

• Verified date: November 2014
• Source: DongGuk University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: July 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 84 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Postcholecystectomy Syndrome
• Syndrome

Intervention

Drug:
• Rowachol

• Placebo

Locations

Country	Name	City	State
Korea, Republic of	DongGuk University Ilsan Hospital	Goyang	Gyeonggi
Korea, Republic of	Chung-Ang University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
DongGuk University	Pharmbio Korea Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No