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Effect of Rowachol on Prevention of Postcholecystectomy Syndrome

Primary Purpose

Postcholecystectomy Syndrome

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Rowachol

Placebo

About this trial

This is an interventional prevention trial for Postcholecystectomy Syndrome focused on measuring postcholecystectomy syndrome, laparoscopic cholecystectomy, Rowachol

Eligibility Criteria

18 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

DongGuk University Ilsan Hospital
Chung-Ang University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rowachol

Placebo

Arm Description

Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months

Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT01765465

First Posted

January 7, 2013

Last Updated

November 16, 2014

Sponsor

DongGuk University

Collaborators

Pharmbio Korea Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01765465

Brief Title

Effect of Rowachol on Prevention of Postcholecystectomy Syndrome

Official Title

Effect of Rowachol on Prevention of Postcholecystectomy Syndrome After Laparoscopic Cholecystectomy

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

DongGuk University

Collaborators

Pharmbio Korea Co., Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postcholecystectomy Syndrome

Keywords

postcholecystectomy syndrome, laparoscopic cholecystectomy, Rowachol

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

138 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rowachol

Arm Type

Experimental

Arm Description

Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months

Intervention Type

Drug

Intervention Name(s)

Rowachol

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

the Number of the Participants Have Postoperative RUQ Pain

Description

Time Frame

postoperative 3-month

Secondary Outcome Measure Information:

Title

Laboratory Test Results of Postoperative 3-month(Total Bilirubin, Direct Bilirubin)

Description

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.

Time Frame

postoperative 3-month

Title

Laboratory Test Results of Postoperative 3-month(Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase)

Description

Time Frame

postoperative 3-month

Title

Laboratory Test Results of Postoperative 3-month(WBC Count)

Description

laboratory test results(WBC count) measured at postoperative 3-month of Rowachol group and placebo group. each result is mean values.

Time Frame

postoperative 3-month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

84 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

In Woong Han, M.D.

Organizational Affiliation

DongGuk University College of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

DongGuk University Ilsan Hospital

City

Goyang

State/Province

Gyeonggi

ZIP/Postal Code

410-773

Country

Korea, Republic of

Facility Name

Chung-Ang University Hospital

City

Seoul

ZIP/Postal Code

156-755

Country

Korea, Republic of

12. IPD Sharing Statement

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Effect of Rowachol on Prevention of Postcholecystectomy Syndrome

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