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Laparoscopic Appendectomy for Uncomplicated Appendicitis: Does Antimicrobial Prophylaxis Really Matter?

Primary Purpose

Appendicitis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cefamezin 1g IV
metronidazole 500 mg IV
Placebo
Sponsored by
HaEmek Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Appendicitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Established diagnosis of acute appendicitis based on clinical examination, US and/or computed tomographic (CT) scan, and acute uncomplicated appendicitis at laparoscopic appendectomy.

Exclusion Criteria:

  • Patients with a documented allergy to any of the medications in the trial.
  • Those with an abscess identified by computed tomographic (CT) scan before surgery are not included in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Placebo Comparator

    Arm Label

    Antibiotics perioperative

    placebo - No Antibiotics perioperative

    Arm Description

    dose of perioperative antibiotics (cefamezin 1g IV; metronidazole 500 mg IV) This is the standard of care of the department

    The intervention is No Antibiotics perioperative

    Outcomes

    Primary Outcome Measures

    The main target-point of the study is surgical site infection (SSI), defined according to the Centers for Disease Control (CDC).
    Criteria for a superficial incisional SSI are an infection occurring at the incision site within 30 days after surgery that involved only the skin and subcutaneous tissue and at least one of the following: purulent drainage from the incision; an organism isolated from a culture of fluid from the superficial incision; incisional pain, tenderness, localized swelling, redness, or heat, and the wound was opened;

    Secondary Outcome Measures

    Full Information

    First Posted
    March 15, 2015
    Last Updated
    March 26, 2015
    Sponsor
    HaEmek Medical Center, Israel
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02404064
    Brief Title
    Laparoscopic Appendectomy for Uncomplicated Appendicitis: Does Antimicrobial Prophylaxis Really Matter?
    Official Title
    Laparoscopic Appendectomy for Uncomplicated Appendicitis: Does Antimicrobial Prophylaxis Really Matter? Randomized Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2015 (undefined)
    Primary Completion Date
    March 2015 (Anticipated)
    Study Completion Date
    March 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    HaEmek Medical Center, Israel

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To compare surgical site infection (SSI) rate in patients undergoing laparoscopic appendectomy for acute uncomplicated appendicitis and treated with single dose regime of antibiotics versus group of patients undergoing laparoscopic appendectomy without antibiotics treatment. Patient will be given either single dose of perioperative antibiotics or no antibiotics before surgery.
    Detailed Description
    Laparoscopic appendectomies are performed by one of the 6 institutional attending surgeons. US and/or abdominal CT scans are obtained as clinically necessary to make the diagnosis of appendicitis. All of the appendectomies are initiated laparoscopically. Postoperative orders are controlled via a standard electronic order set for all operations. Patients found to have acute uncomplicated appendicitis at appendectomy will be randomized to either single dose of perioperative antibiotics /On the second post-operative day the patient who has no fever and tolerating a regular diet, will be discharged home without oral antibiotics. On the post-operative, day seven after surgery all patients will be examined in the outpatient clinic on the presence of surgical site infection. then will be followed for a 30 days after surgery .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Appendicitis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    288 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Antibiotics perioperative
    Arm Type
    Other
    Arm Description
    dose of perioperative antibiotics (cefamezin 1g IV; metronidazole 500 mg IV) This is the standard of care of the department
    Arm Title
    placebo - No Antibiotics perioperative
    Arm Type
    Placebo Comparator
    Arm Description
    The intervention is No Antibiotics perioperative
    Intervention Type
    Drug
    Intervention Name(s)
    cefamezin 1g IV
    Other Intervention Name(s)
    Cefotaxime
    Intervention Description
    perioperative antibiotics (Cefamizin 1g IV; )
    Intervention Type
    Drug
    Intervention Name(s)
    metronidazole 500 mg IV
    Other Intervention Name(s)
    falgyl
    Intervention Description
    perioperative antibiotics (metronidazole 500 mg IV )
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    No perioperative antibiotics
    Primary Outcome Measure Information:
    Title
    The main target-point of the study is surgical site infection (SSI), defined according to the Centers for Disease Control (CDC).
    Description
    Criteria for a superficial incisional SSI are an infection occurring at the incision site within 30 days after surgery that involved only the skin and subcutaneous tissue and at least one of the following: purulent drainage from the incision; an organism isolated from a culture of fluid from the superficial incision; incisional pain, tenderness, localized swelling, redness, or heat, and the wound was opened;
    Time Frame
    30 Days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Established diagnosis of acute appendicitis based on clinical examination, US and/or computed tomographic (CT) scan, and acute uncomplicated appendicitis at laparoscopic appendectomy. Exclusion Criteria: Patients with a documented allergy to any of the medications in the trial. Those with an abscess identified by computed tomographic (CT) scan before surgery are not included in the study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dan Hershko, Professor
    Phone
    972+46494391
    Email
    dan_he@clalit.org.il
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dan Hershko, Professor
    Organizational Affiliation
    haemek medical center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Laparoscopic Appendectomy for Uncomplicated Appendicitis: Does Antimicrobial Prophylaxis Really Matter?

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