Skip to content

Effectiveness of Prophylactic Antibiotics Therapy in Laparoscopic Cholecystectomy on Infection Rate

Prospective Randomized Control Study of Clinical Effectiveness of Prophylactic Antibiotics Therapy in Laparoscopic Cholecystectomy on Infection Rate

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04726046
Enrollment
529
Registered
2021-01-27
Start date
2014-04-01
Completion date
2017-09-25
Last updated
2021-01-27

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

Conditions

Cholecystitis

Keywords

GB stone

Brief summary

529 patients performed elective LCC at Chonbuk National University Hospital between April 2014 and August 2015. Total 509 patients were enrolled by inclusion criteria. They were randomized studied by comparing with antibiotic group (n=249, AG, cefotetan 1g, 1 dose/prophylactic) and non-antibiotic group (n=260, NAG) by table of random numbers. The clinical variables were pre and post-operatively blood tests enclude WBC, ESR, CRP, body temperatures, symptoms and imaging of chest x-ray to evaluate the infections.

Detailed description

529 patients performed elective LCC at Chonbuk National University Hospital between April 2014 and August 2015. Total 509 patients were enrolled by inclusion criteria. They were randomized studied by comparing with antibiotic group (n=249, AG, cefotetan 1g, 1 dose/prophylactic) and non-antibiotic group (n=260, NAG) by table of random numbers. The clinical variables were pre and post-operatively blood tests enclude WBC, ESR, CRP, body temperatures, symptoms and imaging of chest x-ray to evaluate the infections.

Interventions

Cefotetan (as Disodium) 1 GM Injection before surgery

Sponsors

Chonbuk National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

patients who have diagnosed -cholecystitis with / without GB stone, GB polyp

Exclusion criteria

1. Suspected cholangitis and GB cancer 2. CBD stone history 3. Preoperative administration of antibiotics within 7days. 4. Suspected pregnancy 5. Open conversion. 6. Patients refuse this study

Design outcomes

Primary

MeasureTime frameDescription
surgical complication30dayssurgical site infection

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026