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NCT04726046 Clinical Trial

Effectiveness of Prophylactic Antibiotics Therapy in Laparoscopic Cholecystectomy on Infection Rate

Cholecystitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04726046
Other study ID # ChonbukNUH
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date April 1, 2014
Est. completion date September 25, 2017

Study information
Verified date September 2017
Source Chonbuk National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 529
Est. completion date September 25, 2017
Est. primary completion date August 1, 2015
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Cefotetan
Cefotetan (as Disodium) 1 GM Injection before surgery

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Chonbuk National University Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary surgical complication surgical site infection 30days
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