NCT01765465

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
5 months until next milestone

Results Posted

Study results publicly available

November 21, 2014

Completed
Last Updated

November 21, 2014

Status Verified

November 1, 2014

Enrollment Period

1.3 years

First QC Date

January 7, 2013

Results QC Date

October 15, 2014

Last Update Submit

November 16, 2014

Conditions

Postcholecystectomy Syndrome

Keywords

postcholecystectomy syndromelaparoscopic cholecystectomyRowachol

Outcome Measures

Primary Outcomes (1)

  • 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.

    postoperative 3-month

Secondary Outcomes (3)

  • Laboratory Test Results of Postoperative 3-month(Total Bilirubin, Direct Bilirubin)

    postoperative 3-month

  • Laboratory Test Results of Postoperative 3-month(Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase)

    postoperative 3-month

  • Laboratory Test Results of Postoperative 3-month(WBC Count)

    postoperative 3-month

Study Arms (2)

Rowachol

EXPERIMENTAL

Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months

Drug: Rowachol

Placebo

PLACEBO COMPARATOR

Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months

Drug: Placebo

Interventions

RowacholDRUG
Rowachol
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with pathologic diseases scheduled for laparoscopic cholecystectomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

DongGuk University Ilsan Hospital

Goyang-si, Gyeonggi-do, 410-773, South Korea

Location

Chung-Ang University Hospital

Seoul, 156-755, South Korea

Location

MeSH Terms

Conditions

Postcholecystectomy Syndrome

Interventions

Rowachol

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. In Woong Han
Organization
DongGuk University Ilsan Hospital
cardioman76@gmail.com

Study Officials

  • In Woong Han, M.D.

    DongGuk University College of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 7, 2013

First Posted

January 10, 2013

Study Start

January 1, 2013

Primary Completion

May 1, 2014

Study Completion

July 1, 2014

Last Updated

November 21, 2014

Results First Posted

November 21, 2014

Record last verified: 2014-11

Locations

KR(2)