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
About this trial
This is an interventional prevention trial for Appendicitis
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
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
NCT ID
NCT02404064
First Posted
March 15, 2015
Last Updated
March 26, 2015
Sponsor
HaEmek Medical Center, Israel
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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