Cholecystitis, Acute, Cholecystitis, Chronic
Conditions
Brief summary
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
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.
Interventions
DRUGBDD with UDCA
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
DRUGPlacebo
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
Sponsors
Ewha Womans University Mokdong Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Alanine Aminotransferase | Postoperative 30 days | Serum Alanine Aminotransferase level (U/ml) (continuous variable) |
| Serum Aspartate Aminotransferase | Postoperative 30 days | Serum aspartate aminotransferase level (U/ml) (continuous variable) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GIQLI (Gastrointestinal Quality of Life Index) | Postoperative 30 days | Score of Quastionare for postoperative quality of life by GIQLI (Range, 0 - 180) |
Countries
South Korea
Contacts
Primary ContactHuisong Lee, M.D., Ph.D.
Outcome results
None listed