Trial Outcomes & Findings for Effect of Rowachol on Prevention of Postcholecystectomy Syndrome (NCT NCT01765465)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

138 participants

Primary outcome timeframe

postoperative 3-month

Results posted on

2014-11-21

Participant Flow

Participant milestones

Participant milestones
Measure	Rowachol Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months Rowachol	Placebo Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months Placebo
Overall Study STARTED	71	67
Overall Study COMPLETED	64	63
Overall Study NOT COMPLETED	7	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Rowachol on Prevention of Postcholecystectomy Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rowachol n=71 Participants Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months Rowachol	Placebo n=67 Participants Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months Placebo	Total n=138 Participants Total of all reporting groups
Age, Continuous	51.48 years STANDARD_DEVIATION 15.56 • n=93 Participants	47.99 years STANDARD_DEVIATION 13.81 • n=4 Participants	49.78 years STANDARD_DEVIATION 14.79 • n=27 Participants
Sex: Female, Male Female	45 Participants n=93 Participants	34 Participants n=4 Participants	79 Participants n=27 Participants
Sex: Female, Male Male	26 Participants n=93 Participants	33 Participants n=4 Participants	59 Participants n=27 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Rowachol n=64 Participants Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months Rowachol	Placebo n=63 Participants Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months Placebo
the Number of the Participants Have Postoperative RUQ Pain	3 number of participants	9 number of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Rowachol n=64 Participants Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months Rowachol	Placebo n=63 Participants Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months Placebo
Laboratory Test Results of Postoperative 3-month(Total Bilirubin, Direct Bilirubin) Total bilirubin	0.7 mg/dL Standard Deviation 0.5	0.6 mg/dL Standard Deviation 0.2
Laboratory Test Results of Postoperative 3-month(Total Bilirubin, Direct Bilirubin) Direct bilirubin	0.3 mg/dL Standard Deviation 0.3	0.2 mg/dL Standard Deviation 0.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Rowachol n=64 Participants Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months Rowachol	Placebo n=63 Participants Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months Placebo
Laboratory Test Results of Postoperative 3-month(Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase) Alkaline phosphatase	242.8 IU/dL Standard Deviation 449.8	209.6 IU/dL Standard Deviation 145.5
Laboratory Test Results of Postoperative 3-month(Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase) Aspartate aminotransferase	105.1 IU/dL Standard Deviation 60.5	50.8 IU/dL Standard Deviation 41.2
Laboratory Test Results of Postoperative 3-month(Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase) Alanine aminotransferase	44.3 IU/dL Standard Deviation 43.8	56.1 IU/dL Standard Deviation 49.1

SECONDARY outcome

Timeframe: postoperative 3-month

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

Outcome measures

Outcome measures
Measure	Rowachol n=64 Participants Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months Rowachol	Placebo n=63 Participants Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months Placebo
Laboratory Test Results of Postoperative 3-month(WBC Count)	6.8 cells (10^6/µl) Standard Deviation 2.1	7.2 cells (10^6/µl) Standard Deviation 2.4

Adverse Events

Rowachol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Rowachol n=64 participants at risk Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months Rowachol	Placebo n=63 participants at risk Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months Placebo
Hepatobiliary disorders Post operative minor bile leak	0.00% 0/64 • postoperative 3 months	1.6% 1/63 • Number of events 1 • postoperative 3 months

Additional Information

Dr. In Woong Han

DongGuk University Ilsan Hospital

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place