Effect of Rowachol on Prevention of Postcholecystectomy Syndrome

Effect of Rowachol on Prevention of Postcholecystectomy Syndrome After Laparoscopic Cholecystectomy

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 Overview

• Status: Completed
• Conditions: Postcholecystectomy Syndrome
• Intervention / Treatment: Drug: Placebo; Drug: Rowachol

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 156-755
    • Chung-Ang University Hospital
  • Gyeonggi
    • Goyang, Gyeonggi, Korea, Republic of, 410-773
      • Dongguk University Ilsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 84 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: DongGuk University
• Collaborators: Pharmbio Korea Co., Ltd.
• Investigators: Principal Investigator: In Woong Han, M.D., DongGuk University College of Medicine

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: January 7, 2013
• First Submitted That Met QC Criteria: January 9, 2013
• First Posted (Estimate): January 10, 2013

Study Record Updates

• Last Update Posted (Estimate): November 21, 2014
• Last Update Submitted That Met QC Criteria: November 16, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: laparoscopic cholecystectomy; postcholecystectomy syndrome; Rowachol
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Disease; Biliary Tract Diseases; Syndrome; Postcholecystectomy Syndrome
• Other Study ID Numbers: S-2012-E0816-00001