Postcholecystectomy SyndromePhase 4NCT01765465
Effect of Rowachol on Prevention of Postcholecystectomy Syndrome
A Phase 4 study testing Rowachol in people with Postcholecystectomy Syndrome, run by DongGuk University at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Postcholecystectomy Syndrome
- What is being tested?
- Rowachol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Jan 2013to Jul 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with pathologic diseases scheduled for laparoscopic cholecystectomy
Who cannot join
- 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
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- Participation in another intervention-trial with interference of a primary or secondary endpoint of this study
- Lack of compliance
- Lack of informed consent
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
DongGuk University Ilsan Hospital
Goyang-si, Gyeonggi-do, 410-773
Chung-Ang University Hospital
Seoul, 156-755
About this study
Official title: Effect of Rowachol on Prevention of Postcholecystectomy Syndrome After Laparoscopic Cholecystectomy
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
- Conditions
- Postcholecystectomy Syndrome
- Being tested
- Rowachol, Placebo
- Keywords
- postcholecystectomy syndrome, laparoscopic cholecystectomy, Rowachol
- Medical subject headings
- Postcholecystectomy Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RowacholDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Rowachol | Experimental | Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months Receives: Drug: Rowachol |
| Placebo | Placebo comparator | Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: postoperative 3-month
Secondary outcomes (3)
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.
Measured: postoperative 3-month
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.
Measured: postoperative 3-month
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.
Measured: postoperative 3-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionMay 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postcholecystectomy SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- DongGuk University
- Sponsor type
- University, hospital or other
- Collaborators
- Pharmbio Korea Co., Ltd.
- Responsible party
- Principal investigator, In Woong Han, DongGuk University
- Investigators
- In Woong Han, M.D., Principal investigator, DongGuk University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01765465
- Sponsor's protocol ID
- S-2012-E0816-00001
- Status last verified
- Nov 2014
- First submitted
- 7 Jan 2013
- Last updated
- 21 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rowachol on Prevention of Postcholecystectomy Syndrome After Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT01765465
- Acronym / sponsor ID
- S-2012-E0816-00001
- Conditions
- Postcholecystectomy Syndrome
- Keywords
- postcholecystectomy syndrome, laparoscopic cholecystectomy, Rowachol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- DongGuk UniversityUniversity, hospital or other
- Collaborators
- Pharmbio Korea Co., Ltd.
- Study start
- Jan 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 10 Jan 2013 (estimated)
- Results
- Posted 21 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rowachol | Experimental | Drug: RowacholRowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo treatment with 200mg PO tid, on postoperative 1 days to 3 months |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with pathologic diseases scheduled for laparoscopic cholecystectomy
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rowachol | Drug | Rowachol |
| Placebo | Drug | Placebo |
Primary outcome
the Number of the Participants Have Postoperative RUQ Pain
Time frame: 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.
3 secondary outcomes
Laboratory Test Results of Postoperative 3-month(Total Bilirubin, Direct Bilirubin)
Time frame: postoperative 3-month
Laboratory Test Results of Postoperative 3-month(Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase)
Time frame: postoperative 3-month
Laboratory Test Results of Postoperative 3-month(WBC Count)
Time frame: postoperative 3-month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Postcholecystectomy Syndrome
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Pharmacokinetics, Bioequivalence, and Safety Study of Trimedat® 76,95 mg Orally Disintegrating Tablets and Trimedat® 100 mg Tablets in Healthy Volunteers.
Irritable Bowel Syndrome, Gallstone Disease
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Fatty Liver in Long Standing Cholecystectomy
Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD)-Post-cholecystectomy Metabolic Changes -Hepatic Steatosis
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Post-Cholecystectomy Quality of Life
Gallstone
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
In Woong Han, M.D. principal investigator
DongGuk University College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rowachol in people with Postcholecystectomy Syndrome, run by DongGuk University at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Number of the Participants Have Postoperative RUQ Pain (time frame: postoperative 3-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2014.