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NCT04661371

Necessity of Preoperative Empirical Antibiotic Use in Acute Cholecystitis

Status unknown NA Last updated 23 December 2020
What this trial tests

NA trial testing Laparoscopic cholecystectomy in Cholecystitis, Acute in 180 participants. Status unknown.

Timeline
2 March 2021
Primary endpoint
30 September 2021
30 December 2021

Quick facts

Lead sponsorSeoul St. Mary's Hospital
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment180
Start date2 March 2021
Primary completion30 September 2021
Estimated completion30 December 2021
Sites1 location across South Korea

Drugs / interventions tested

Conditions studied

Sponsor

Seoul St. Mary's Hospital

Who can join

Adults 19 to 70, any sex, with Cholecystitis, Acute. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Preoperative antibiotic prophylaxis in acute cholecystectomy: a systematic review and meta-analysis of randomised controlled trials.
    Singh A, Kaur M, Swaminathan C, Subramanian A, et al · · 2023 · cited 6× · PMID 38021359 · DOI 10.21037/tgh-23-48

Verify or expand the search:

Other trials of Laparoscopic cholecystectomy

Trials testing the same drug.

Other recruiting trials for Cholecystitis, Acute

Currently open trials in the same condition.

Other Seoul St. Mary's Hospital trials

Trials by the same sponsor.

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Data sources for this page

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