Necessity and 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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0008240

Enrollment

370

Registered

2023-02-27

Start date

2023-03-02

Completion date

Unknown

Last updated

2023-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : The control group administers 2g of Cefobactam every 12 hours through intravenous injection on the day of surgery, and the experimental group administers 10cc of physiological saline without an

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Patients who are scheduled to undergo laparoscopic surgery among patients with acute cholecystitis who have no evidence of systemic infection between the ages of 19 and 70 ? Patients with acute cholecystitis with preserved gallbladder walls in the group of patients with acute cholecystitis (grade I by Tokyo guidelines) and moderate (grade II) ? Cholecystitis with gallbladder wall thickness of more than 4mm or adhesion to surrounding organs due to gallbladder inflammation ? A person who voluntarily signs a written consent form after hearing and understanding the description of this clinical trial

Exclusion criteria

Exclusion criteria: ? Those who are scheduled to undergo elective gallbladder surgery (chronic cholecystitis, etc.) ? gallbladder disease, not inflammatory disease (GB Cancer, GB polyp) ? Among the patients with acute cholecystitis, patients with grade II or III by Tokyo guidelines with unpreserved gallbladder walls ? Pregnant or lactating women ? A person who performs surgery simultaneously due to other organ diseases. ? Those with immunosuppressive and hemorrhagic tendencies ? A person who performed percutaneous cholecyst drainage (PTGBD) before alcohol ? A person who is required to install a drainage tube during surgery ? People who overreact to cephalosporin antibiotics. ? A person who participates in another clinical trial within 3 months prior to screening ? Other persons deemed unfit for participation in this clinical trial by the tester;

Design outcomes

Primary

Measure	Time frame
incidence of postoperative infection-related complications	—

Secondary

Measure	Time frame
pain after surgery;length of hospitalization;Re-admission;complications other than infection	—

Countries

Korea, Republic of

Contacts

Public ContactSunghyun Lee

The Catholic University of Korea, Seoul St. Mary's Hospital

Outcome results