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Effect of Rowachol on Prevention of Postcholecystectomy Syndrome

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ClinicalTrials.gov Identifier: NCT01765465
Recruitment Status : Completed
First Posted : January 10, 2013
Results First Posted : November 21, 2014
Last Update Posted : November 21, 2014
Sponsor:
Collaborator:
Pharmbio Korea Co., Ltd.
Information provided by (Responsible Party):
In Woong Han, DongGuk University

Brief 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


Condition or disease Intervention/treatment Phase
Postcholecystectomy Syndrome Drug: Rowachol Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Effect of Rowachol on Prevention of Postcholecystectomy Syndrome After Laparoscopic Cholecystectomy
Study Start Date : January 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : July 2014

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



Primary Outcome Measures :
  1. the Number of the Participants Have Postoperative RUQ Pain [ Time Frame: postoperative 3-month ]

    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 :
  1. Laboratory Test Results of Postoperative 3-month(Total Bilirubin, Direct Bilirubin) [ Time Frame: postoperative 3-month ]

    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.


  2. Laboratory Test Results of Postoperative 3-month(Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase) [ Time Frame: postoperative 3-month ]

    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.


  3. Laboratory Test Results of Postoperative 3-month(WBC Count) [ Time Frame: postoperative 3-month ]

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

    each result is mean values.




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Ages Eligible for Study:   18 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: In Woong Han, Assistant Professor, DongGuk University
ClinicalTrials.gov Identifier: NCT01765465     History of Changes
Other Study ID Numbers: S-2012-E0816-00001
First Posted: January 10, 2013    Key Record Dates
Results First Posted: November 21, 2014
Last Update Posted: November 21, 2014
Last Verified: November 2014

Keywords provided by In Woong Han, DongGuk University:
postcholecystectomy syndrome
laparoscopic cholecystectomy
Rowachol

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