Effect of Rowachol on Prevention of Postcholecystectomy Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by DongGuk University
Sponsor:
Collaborator:
Pharmbio Korea Co., Ltd.
Information provided by (Responsible Party):
In Woong Han, DongGuk University
ClinicalTrials.gov Identifier:
NCT01765465
First received: January 7, 2013
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Postcholecystectomy Syndrome
Drug: Rowachol
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Effect of Rowachol on Prevention of Postcholecystectomy Syndrome After Laparoscopic Cholecystectomy

Further study details as provided by DongGuk University:

Primary Outcome Measures:
  • Right upper quadrant(RUQ) pain score [ Time Frame: baseline and postoperative 3 months after ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Changing pattern of liver function test [ Time Frame: baseline and postoperative 3 months after ] [ Designated as safety issue: No ]
    3 months minus baseline


Estimated Enrollment: 138
Study Start Date: January 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 84 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01765465

Contacts
Contact: In Woong Han, M.D. 82-31-961-7567 cardioman76@gmail.com

Locations
Korea, Republic of
DongGuk University Ilsan Hospital Recruiting
Goyang, Gyeonggi, Korea, Republic of, 410-773
Contact: In Woong Han, M.D.    82-31-961-7567    cardioman76@gmail.com   
Contact: Min Gu Oh, M.D., PhD.    82-31-961-7261    mgo59@hanmail.net   
Principal Investigator: In Woong Han, M.D.         
Sub-Investigator: Min Gu Oh, M.D., PhD.         
Chung-Ang University Hospital Recruiting
Seoul, Korea, Republic of, 156-755
Contact: Seung Eun Lee, M.D., PhD.    82-10-8912-3073    selee@cau.ac.kr   
Principal Investigator: Seung Eun Lee, M.D., PhD.         
Sponsors and Collaborators
DongGuk University
Pharmbio Korea Co., Ltd.
Investigators
Principal Investigator: In Woong Han, M.D. DongGuk University College of Medicine
  More Information

No publications provided

Responsible Party: In Woong Han, Assistant Professor, DongGuk University
ClinicalTrials.gov Identifier: NCT01765465     History of Changes
Other Study ID Numbers: S-2012-E0816-00001
Study First Received: January 7, 2013
Last Updated: April 2, 2014
Health Authority: Korea: Ministry for Health, Welfare and Family Affairs

Keywords provided by DongGuk University:
postcholecystectomy syndrome
laparoscopic cholecystectomy
Rowachol

Additional relevant MeSH terms:
Postcholecystectomy Syndrome
Syndrome
Biliary Tract Diseases
Digestive System Diseases
Disease
Pathologic Processes
Postoperative Complications

ClinicalTrials.gov processed this record on October 20, 2014