Effectiveness of Prophylactic Antibiotics Therapy in Laparoscopic Cholecystectomy on Infection Rate

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

529 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-01

Study Completion Date

2017-09-25

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cholecystitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Antibiotic treatment group

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

Group Type EXPERIMENTAL

Cefotetan

Intervention Type DRUG

Cefotetan (as Disodium) 1 GM Injection before surgery

Non-antibiotic treatment group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cefotetan

Cefotetan (as Disodium) 1 GM Injection before surgery

Intervention Type DRUG

Other Intervention Names

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antibiotics group

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No