Effectiveness of Prophylactic Antibiotics Therapy in Laparoscopic Cholecystectomy on Infection Rate

Chonbuk National University

Status and phase: Completed; Phase 1

Conditions: Cholecystitis

Treatments: Drug: Cefotetan

Study type: Interventional

Funder types: Other

Identifiers

NCT04726046

ChonbukNUH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 529 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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529 participants in 2 patient groups

Antibiotic treatment group

Experimental group

Description:

They were Antibiotic treatment group (AG, cefotetan 1g, 1 dose/prophylactic) before surgery.

Treatment:

Drug: Cefotetan

Non-antibiotic treatment group

No Intervention group

Description:

They were Non-antibiotics treatment such as cefotetan 1g before surgery.