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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
172
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
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
Ewha Womans University Mokdong Hospital
Seoul, South Korea
RECRUITINGSerum Aspartate Aminotransferase
Serum aspartate aminotransferase level (U/ml) (continuous variable)
Time frame: Postoperative 30 days
Serum Alanine Aminotransferase
Serum Alanine Aminotransferase level (U/ml) (continuous variable)
Time frame: Postoperative 30 days
GIQLI (Gastrointestinal Quality of Life Index)
Score of Quastionare for postoperative quality of life by GIQLI (Range, 0 - 180)
Time frame: Postoperative 30 days
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