Effectiveness of Prophylactic Antibiotics Therapy in Laparoscopic Cholecystectomy on Infection Rate

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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