Postcholecystectomy Syndrome
Conditions
Keywords
postcholecystectomy syndrome, laparoscopic cholecystectomy, Rowachol
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
Interventions
DRUGRowachol
DRUGPlacebo
Sponsors
Pharmbio Korea Co., Ltd.
DongGuk University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rowachol Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months
Rowachol | 71 |
| Placebo Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months
Placebo | 67 |
| Total | 138 |
Baseline characteristics
| Characteristic | Rowachol | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 51.48 years STANDARD_DEVIATION 15.56 | 47.99 years STANDARD_DEVIATION 13.81 | 49.78 years STANDARD_DEVIATION 14.79 |
| Sex: Female, Male Female | 45 Participants | 34 Participants | 79 Participants |
| Sex: Female, Male Male | 26 Participants | 33 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 64 | 1 / 63 |
| serious Total, serious adverse events | 0 / 64 | 0 / 63 |
Outcome results
Primary
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.
Time frame: postoperative 3-month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rowachol | the Number of the Participants Have Postoperative RUQ Pain | 3 number of participants |
| Placebo | the Number of the Participants Have Postoperative RUQ Pain | 9 number of participants |
Secondary
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.
Time frame: postoperative 3-month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rowachol | Laboratory Test Results of Postoperative 3-month(Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase) | Alkaline phosphatase | 242.8 IU/dL | Standard Deviation 449.8 |
| Rowachol | Laboratory Test Results of Postoperative 3-month(Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase) | Aspartate aminotransferase | 105.1 IU/dL | Standard Deviation 60.5 |
| Rowachol | Laboratory Test Results of Postoperative 3-month(Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase) | Alanine aminotransferase | 44.3 IU/dL | Standard Deviation 43.8 |
| Placebo | Laboratory Test Results of Postoperative 3-month(Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase) | Alkaline phosphatase | 209.6 IU/dL | Standard Deviation 145.5 |
| Placebo | Laboratory Test Results of Postoperative 3-month(Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase) | Aspartate aminotransferase | 50.8 IU/dL | Standard Deviation 41.2 |
| Placebo | Laboratory Test Results of Postoperative 3-month(Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase) | Alanine aminotransferase | 56.1 IU/dL | Standard Deviation 49.1 |
Secondary
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.
Time frame: postoperative 3-month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rowachol | Laboratory Test Results of Postoperative 3-month(Total Bilirubin, Direct Bilirubin) | Total bilirubin | 0.7 mg/dL | Standard Deviation 0.5 |
| Rowachol | Laboratory Test Results of Postoperative 3-month(Total Bilirubin, Direct Bilirubin) | Direct bilirubin | 0.3 mg/dL | Standard Deviation 0.3 |
| Placebo | Laboratory Test Results of Postoperative 3-month(Total Bilirubin, Direct Bilirubin) | Total bilirubin | 0.6 mg/dL | Standard Deviation 0.2 |
| Placebo | Laboratory Test Results of Postoperative 3-month(Total Bilirubin, Direct Bilirubin) | Direct bilirubin | 0.2 mg/dL | Standard Deviation 0.2 |
Secondary
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.
Time frame: postoperative 3-month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rowachol | Laboratory Test Results of Postoperative 3-month(WBC Count) | 6.8 cells (10^6/µl) | Standard Deviation 2.1 |
| Placebo | Laboratory Test Results of Postoperative 3-month(WBC Count) | 7.2 cells (10^6/µl) | Standard Deviation 2.4 |