Brief Title
Effectiveness of Prophylactic Antibiotics Therapy in Laparoscopic Cholecystectomy on Infection Rate
Official Title
Prospective Randomized Control Study of Clinical Effectiveness of Prophylactic Antibiotics Therapy in Laparoscopic Cholecystectomy on Infection Rate
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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
surgical complication
Condition
Cholecystitis
Intervention
Cefotetan
Study Arms / Comparison Groups
Antibiotic treatment group
Description: They were Antibiotic treatment group (AG, cefotetan 1g, 1 dose/prophylactic) before surgery.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
529
Start Date
April 1, 2014
Completion Date
September 25, 2017
Primary Completion Date
August 1, 2015
Eligibility Criteria
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
Gender
All
Ages
20 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Jae Do Yang, ,
Administrative Informations
NCT ID
NCT04726046
Organization ID
ChonbukNUH
Responsible Party
Sponsor
Study Sponsor
Chonbuk National University Hospital
Study Sponsor
Jae Do Yang, Study Director, Chonkbuk national university
Verification Date
September 2017