MedTrace Logo

Empirical Antibiotics in Acute Inflammatory Gallbladder Disease

NCT04321902 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2020-03-25

No results posted yet for this study

Summary

In this study, the investigators compared the surgical outcomes according to the type of antibiotics before surgery in patients who did not have evidence of systemic infection during acute cholecystitis.

The primary purpose of the study was to determine the type of preoperative antibiotics in patients who were scheduled for cholecystectomy, because of the mild (grade I) or moderate (grade 2) acute inflammatory gallbladder disease without gallbladder perforation. The investigators compared the incidence of postoperative complications according to the types of preoperative antibiotics(the first-generation vs second-generation cephalosporin).

The secondary purpose of the study was to confirm the clinical efficacy of first-generation cephalosporins following the use of empirical antibiotics. And the investigators compare with postoperative pain, postoperative hospital stay, re-hospitalization, and need for additional treatment. In addition, the investigators compare the postoperative complications, such as atelectasis and postoperative ileus.

Conditions

  • Cholecystitis, Acute

Interventions

PROCEDURE

Laparoscopic cholecystectomy

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 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)

Sponsors & Collaborators

  • Seoul St. Mary's Hospital

    lead OTHER

Principal Investigators

  • Sung eun Park, MD · The Catholic University of Korea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-02
Primary Completion
2020-12-30
Completion
2021-12-30

Countries

  • South Korea

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04321902 on ClinicalTrials.gov