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

Study Overview
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Brief Summary
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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
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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 .

Official Title
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Laparoscopic Appendectomy for Uncomplicated Appendicitis: Does Antimicrobial Prophylaxis Really Matter? Randomized Control Trial

Conditions
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Appendicitis

Intervention / Treatment
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* Drug: cefamezin 1g IV
* Drug: metronidazole 500 mg IV
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Antibiotics perioperative<br>dose of perioperative antibiotics (cefamezin 1g IV; metronidazole 500 mg IV) This is the standard of care of the department | Drug: cefamezin 1g IV<br>* perioperative antibiotics (Cefamizin 1g IV; )<br>* Other names: Cefotaxime;Drug: metronidazole 500 mg IV<br>* perioperative antibiotics (metronidazole 500 mg IV )<br>* Other names: falgyl;|
| Placebo Comparator: placebo - No Antibiotics perioperative<br>The intervention is No Antibiotics perioperative | Drug: Placebo<br>* No perioperative antibiotics<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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; | 30 Days |