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Completed

NCT Number: NCT01765465

Effect of Rowachol on Prevention of Postcholecystectomy Syndrome

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

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Key information

Conditions

Postcholecystectomy Syndrome Biliary Tract Diseases Digestive System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

DongGuk University Ilsan Hospital, Goyang-si, Gyeonggi-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rowachol

Drug

Placebo

Drug

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: postoperative 3-month

    laboratory test results(WBC count) measured at postoperative 3-month of Rowachol group and placebo group.

    each result is mean values.

Sponsors and collaborators

Lead sponsor

DongGuk University

Other

Collaborators

  • Pharmbio Korea Co., Ltd.

Registry information

Official study title

Effect of Rowachol on Prevention of Postcholecystectomy Syndrome After Laparoscopic Cholecystectomy

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 10, 2013
Registry last updated
Nov 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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