Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effect of Rowachol on Prevention of Postcholecystectomy Syndrome

This study has been completed.
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: November 16, 2014
Last verified: November 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:
  • the Number of the Participants Have Postoperative RUQ Pain [ Time Frame: postoperative 3-month ] [ 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-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.



Secondary Outcome Measures:
  • Laboratory Test Results of Postoperative 3-month(Total Bilirubin, Direct Bilirubin) [ Time Frame: postoperative 3-month ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

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

    each result is mean values.



Enrollment: 138
Study Start Date: January 2013
Study Completion Date: July 2014
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

Locations
Korea, Republic of
DongGuk University Ilsan Hospital
Goyang, Gyeonggi, Korea, Republic of, 410-773
Chung-Ang University Hospital
Seoul, Korea, Republic of, 156-755
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
Results First Received: October 15, 2014
Last Updated: November 16, 2014
Health Authority: Korea: Ministry for Health and Welfare

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 November 24, 2014