BDD With UDCA Therapy After Laparoscopic Cholecystectomy (BULQ-LC)

Ewha Womans University

Status and phase: Unknown; Phase 3

Conditions: Cholecystitis, Acute; Cholecystitis, Chronic

Treatments: Drug: Placebo; Drug: BDD with UDCA

Study type: Interventional

Funder types: Other

Identifiers

NCT03578055

BULQ-LC trial

Details and patient eligibility

About

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

Full 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.

Enrollment: 172 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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172 participants in 2 patient groups, including a placebo group

BDD with UDCA

Active Comparator group

Description:

Postoperative BDD with UDCA treatment

Treatment:

Drug: BDD with UDCA

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo