Effect of Rowachol on Prevention of Postcholecystectomy Syndrome

DongGuk University

Status and phase

Completed

Phase 4

Conditions

Postcholecystectomy Syndrome

Treatments

Drug: Rowachol

Drug: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01765465

S-2012-E0816-00001

Details and patient eligibility

About

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

Enrollment

138 patients

Sex

All

Ages

18 to 84 years old

Volunteers

No 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