Cholecystitis, Acute Clinical Trial
Official title:
Necessity and Effectiveness of Empirical Antibiotic Use in Mild to Moderate Acute Inflammatory Gallbladder Disease; a Multicenter, Double-blind, Randomized, Placebo-controlled Trial
This clinical trial is an exploratory clinical trial that evaluates the necessity and effectiveness of empirical antibiotic use in mild and moderate acute inflammatory gallbladder diseases that require surgery, and the incidence of postoperative infection-related complications is compared.
Status | Not yet recruiting |
Enrollment | 370 |
Est. completion date | April 30, 2024 |
Est. primary completion date | April 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. among patients with mild acute cholecystitis (grade I by Tokyo guidelines) or moderate acute cholecystitis without evidence of gallbladder perforation(grade II) 2. cholecystitis with a thickness of 4 mm or more on gallbladder in preoperative imaging 3. Gallbladder with surrounding organs due to gallbladder inflammation 4. Patients over 19 years of age, under 70 years of age Exclusion Criteria: 1. patients with elective gallbladder surgery (chronic cholecystitis) 2. gallbladder disease not inflammatory disease (GB cancer, GB polyp) 3. pregnant women, patients under 18 years of age, over 70 years of age 4. patients with simultaneous surgery due to other organ diseases 5. immunosuppressed patients; liver transplant patients, kidney transplant patients, acquired immunodeficiency syndrome patients 6. patients with hemorrhagic tendency, or with hematologic diseases 7. Patients who underwent percutaneous cholecystectomy (PTGBD) |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Department of HBP Surgery, Seoul St. Mary's hospital | Seoul | Seocho-gu, Banopo-dong |
Lead Sponsor | Collaborator |
---|---|
Seoul St. Mary's Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants with Infectious Postoperative Complications | Incidence of infectious postoperative complications in patients who underwent a laparoscopic cholecystectomy due to grade I Tokyo guidelines for acute cholecystitis or grade II Tokyo guidelines for acute cholecystitis except the evidence of gallbladder perforation, with the first-generation cephalosporin and normal saline. | 30 days | |
Secondary | Duration of hospitalization | The duration between the operation day and the day of discharge | Participants will be followed for the duration of hospital stay, an expected average of 2 days |
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