Effect of Rowachol on Prevention of Postcholecystectomy Syndrome

NCT01765465 — Phase 4, Completed, 138 participants, DongGuk University

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Effect of Rowachol on Prevention of Postcholecystectomy Syndrome After Laparoscopic Cholecystectomy

Registry	NCT01765465
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: single, prevention
Enrollment	138 (Actual)
Sponsor	DongGuk University (Other); collaborators: Pharmbio Korea Co., Ltd.
Conditions	Postcholecystectomy Syndrome
Interventions	Rowachol, Placebo (Drug)
Dates	start 2013-01-01, primary completion 2014-05-01, completion 2014-07-01, first posted 2013-01-10, last updated 2014-11-21
Locations	2 sites in South Korea

-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

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+Arms and interventions

Arm	Type	Interventions	Description
Rowachol	Experimental	Drug: Rowachol	Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months
Placebo	Placebo comparator	Drug: Placebo	Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months

Rowachol (Drug)
Placebo (Drug)

+Outcome measures

Primary outcomes

the Number of the Participants Have Postoperative RUQ Pain [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 outcomes

Laboratory Test Results of Postoperative 3-month(Total Bilirubin, Direct Bilirubin) [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.
Laboratory Test Results of Postoperative 3-month(Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase) [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.
Laboratory Test Results of Postoperative 3-month(WBC Count) [postoperative 3-month]: laboratory test results(WBC count) measured at postoperative 3-month of Rowachol group and placebo group. each result is mean values.

+Eligibility

Sex: All, ages: 18 Years to 84 Years

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

+Posted results

Participant flow

Milestone	Rowachol	Placebo
Started	71	67
Completed	64	63
Not completed	7	4

Outcome results

the Number of the Participants Have Postoperative RUQ Pain (Primary), Number, number of participants: Rowachol 3; Placebo 9
Laboratory Test Results of Postoperative 3-month(Total Bilirubin, Direct Bilirubin) (Secondary), Mean, mg/dL: Rowachol 0.7 +/- 0.5; Placebo 0.6 +/- 0.2
Laboratory Test Results of Postoperative 3-month(Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase) (Secondary), Mean, IU/dL: Rowachol 242.8 +/- 449.8; Placebo 209.6 +/- 145.5
Laboratory Test Results of Postoperative 3-month(WBC Count) (Secondary), Mean, cells (10^6/µl): Rowachol 6.8 +/- 2.1; Placebo 7.2 +/- 2.4

Adverse events

Time frame: postoperative 3 months

Arm	Deaths	Serious adverse events	Other adverse events
Rowachol	0	0/64 (0.0%)	0/64 (0.0%)
Placebo	0	0/63 (0.0%)	1/63 (1.6%)

Other adverse events by term

Term	Organ system	Rowachol	Placebo
Post operative minor bile leak	Hepatobiliary disorders	0/64	1/63

+Locations (2)

Facility	City	Country	Status
DongGuk University Ilsan Hospital	Goyang-si, Gyeonggi-do	South Korea
Chung-Ang University Hospital	Seoul	South Korea

+Investigators

In Woong Han, M.D., Principal investigator, DongGuk University College of Medicine

My Notes

Public

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