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Effectiveness of Prophylactic Antibiotics Therapy in Laparoscopic Cholecystectomy on Infection Rate

Primary Purpose

Cholecystitis

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Cefotetan
Sponsored by
Chonbuk National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cholecystitis focused on measuring GB stone

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Antibiotic treatment group

    Non-antibiotic treatment group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    surgical complication
    surgical site infection

    Secondary Outcome Measures

    Full Information

    First Posted
    September 18, 2017
    Last Updated
    January 25, 2021
    Sponsor
    Chonbuk National University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04726046
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1, 2014 (Actual)
    Primary Completion Date
    August 1, 2015 (Actual)
    Study Completion Date
    September 25, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Chonbuk National University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cholecystitis
    Keywords
    GB stone

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    529 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Antibiotic treatment group
    Arm Type
    Experimental
    Arm Description
    They were Antibiotic treatment group (AG, cefotetan 1g, 1 dose/prophylactic) before surgery.
    Arm Title
    Non-antibiotic treatment group
    Arm Type
    No Intervention
    Arm Description
    They were Non-antibiotics treatment such as cefotetan 1g before surgery.
    Intervention Type
    Drug
    Intervention Name(s)
    Cefotetan
    Other Intervention Name(s)
    antibiotics group
    Intervention Description
    Cefotetan (as Disodium) 1 GM Injection before surgery
    Primary Outcome Measure Information:
    Title
    surgical complication
    Description
    surgical site infection
    Time Frame
    30days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients who have diagnosed -cholecystitis with / without GB stone, GB polyp Exclusion Criteria: Suspected cholangitis and GB cancer CBD stone history Preoperative administration of antibiotics within 7days. Suspected pregnancy Open conversion. Patients refuse this study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jae Do Yang
    Organizational Affiliation
    Chonkbuk national university
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effectiveness of Prophylactic Antibiotics Therapy in Laparoscopic Cholecystectomy on Infection Rate

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