Effectiveness of Empirical Antibiotic Use in Mild to Moderate Acute Inflammatory Gallbladder Disease
Necessity and Effectiveness of Empirical Antibiotic Use in Mild to Moderate Acute Inflammatory Gallbladder Disease; a Multicenter, Double-blind, Randomized, Placebo-controlled Trial
1 other identifier
interventional
370
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2022
CompletedFirst Posted
Study publicly available on registry
April 21, 2022
CompletedStudy Start
First participant enrolled
May 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2024
CompletedMay 6, 2022
May 1, 2022
12 months
April 14, 2022
May 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Duration of hospitalization
Participants will be followed for the duration of hospital stay, an expected average of 2 days
Study Arms (2)
The experimental group in acute cholecystitis
EXPERIMENTALinclusion 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 normal saline (Isotonic Sodium Chloride Injection Daihan(50mL/bag)) was used before surgery.
The controled group in acute cholecystitis
EXPERIMENTAL1. 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 First-generation cephalosporin (Cefazolin inj., 1g, Cefazolin sodium, Chong-geun-dang pharm.co.) was used before surgery.
Interventions
Method of operation 1. Surgery was started under general anesthesia 2. A trocar of 10 mm was placed on the navel, 5 mm under the blade, and a 5 mm trocar was placed on the right upper abdomen. 3. Pneumoperitoneum was performed using CO2 gas in the abdominal cavity. 4. Dissection started from Calot's triangle, and the operation was performed by retrograde cholecystectomy. 5. The excised gallbladder was placed in a laparoscopic pocket and extracted through the umbilicus. 6. The trocar was removed, and the skin was sutured On the 1st day after surgery, hematology, blood chemistry, urine, blood clotting, and chest x-rays were performed. (Inspection and treatment were performed according to the current clinical pathway of gallbladder surgery)
Eligibility Criteria
You may qualify if:
- among patients with mild acute cholecystitis (grade I by Tokyo guidelines) or moderate acute cholecystitis without evidence of gallbladder perforation(grade II)
- cholecystitis with a thickness of 4 mm or more on gallbladder in preoperative imaging
- Gallbladder with surrounding organs due to gallbladder inflammation
- Patients over 19 years of age, under 70 years of age
You may not qualify if:
- patients with elective gallbladder surgery (chronic cholecystitis)
- gallbladder disease not inflammatory disease (GB cancer, GB polyp)
- pregnant women, patients under 18 years of age, over 70 years of age
- patients with simultaneous surgery due to other organ diseases
- immunosuppressed patients; liver transplant patients, kidney transplant patients, acquired immunodeficiency syndrome patients
- patients with hemorrhagic tendency, or with hematologic diseases
- Patients who underwent percutaneous cholecystectomy (PTGBD)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of HBP Surgery, Seoul St. Mary's hospital
Seoul, Seocho-gu, Banopo-dong, 137-701, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sung eun Park, MD
The Catholic University of Korea
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 14, 2022
First Posted
April 21, 2022
Study Start
May 1, 2022
Primary Completion
April 30, 2023
Study Completion
April 30, 2024
Last Updated
May 6, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share