Phase 4
N=138
Effect of Rowachol on Prevention of Postcholecystectomy Syndrome
Postcholecystectomy Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01765465 ↗Enrolled (actual)
138
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: the Number of the Participants Have Postoperative RUQ Pain — 3; 9 number of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Rowachol (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- DongGuk University
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY the Number of the Participants Have Postoperative RUQ Pain |
3; 9 | — |
| SECONDARY Laboratory Test Results of Postoperative 3-month(Total Bilirubin, Direct Bilirubin) |
0.7; 0.6; 0.3; 0.2 | — |
| SECONDARY Laboratory Test Results of Postoperative 3-month(Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase) |
242.8; 209.6; 105.1; 50.8; 44.3; 56.1 | — |
| SECONDARY Laboratory Test Results of Postoperative 3-month(WBC Count) |
6.8; 7.2 | — |
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
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
Data sourced from ClinicalTrials.gov (NCT01765465). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.