BDD With UDCA Therapy After Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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Prospective Study for the Effects of Biphenyl Dimethyl Dicarboxylate and Ursodeoxycolic Acid Therapy on Liver Function and Quality of Life After Laparoscopic Cholecystectomy Primary endpoint: peak level of postoperative AST (aspartate transaminase) and postoperative ALT (alanine tansaminase) Secondary endpoint: postoperative GIQLI (Gastrointestinal Quality of Life index) score

Detailed Description
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Because the gallbladder is adjacent to the liver, liver enzymes are often elevated when cholecystitis occurs. BDD and UDCA drugs are known to be effective in preserving liver function. The use of BDD and UDCA drugs in patients with cholecystitis is expected to inhibit elevated liver enzyme levels and to maintain liver function. The aim of this study is to analyze the effects of BDD and UDCA medication on postoperative changes in hepatic enzyme levels and quality of life in patients LFT elevated cholecystitis.

Official Title
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Prospective Study for the Effects of Biphenyl Dimethyl Dicarboxylate and Ursodeoxycolic Acid Therapy on Liver Function and Quality of Life After Laparoscopic Cholecystectomy

Conditions
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Cholecystitis, Acute, Cholecystitis, Chronic

Intervention / Treatment
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* Drug: BDD with UDCA
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for surgery due to chronic cholecystitis and acute cholecystitis Exclusion Criteria: Failure to obtain consent Under 19 years If you have intellectual ability to understand this study When performing cholecystectomy with other operations Total bilirubin levels> 2 mg / dl If you are enrolled in another clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BDD with UDCA<br>Postoperative BDD with UDCA treatment | Drug: BDD with UDCA<br>* Dosage: Udex 1 capsule, 3 times daily Time of administration: 30 minutes after meal Duration of administration: From the day before surgery to 4 weeks after surgery<br>* Other names: UDEX;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Dosage: 1 capsule of placebo, 3 times daily Time of administration: 30 minutes after meal Duration of administration: From the day before surgery to 4 weeks after surgery<br>* Other names: No UDEX;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Aspartate Aminotransferase | Serum aspartate aminotransferase level (U/ml) (continuous variable) | Postoperative 30 days | 
| Serum Alanine Aminotransferase | Serum Alanine Aminotransferase level (U/ml) (continuous variable) | Postoperative 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GIQLI (Gastrointestinal Quality of Life Index) | Score of Quastionare for postoperative quality of life by GIQLI (Range, 0 - 180) | Postoperative 30 days |