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

Not Applicable

• Conditions: Appendicitis
• Interventions: Drug: cefamezin 1g IV; Drug: Placebo; Drug: metronidazole 500 mg IV

• Registration Number: NCT02404064
• Lead Sponsor: HaEmek Medical Center, Israel

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 .

Study Timeline

• Status Verified: 2015-03
• Study Start: 2015-03
• Primary Completion: 2015-03
• Study First Submitted: 2015-03-15
• Study First Submitted QC: 2015-03-26
• Last Update Submitted: 2015-03-26
• Study First Posted: 2015-03-31
• Last Update Posted: 2015-03-31
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 288

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antibiotics perioperative	cefamezin 1g IV	dose of perioperative antibiotics (cefamezin 1g IV; metronidazole 500 mg IV) This is the standard of care of the department
Antibiotics perioperative	metronidazole 500 mg IV	dose of perioperative antibiotics (cefamezin 1g IV; metronidazole 500 mg IV) This is the standard of care of the department
placebo - No Antibiotics perioperative	Placebo	The intervention is No Antibiotics perioperative

Primary Outcome Measures

Name	Time	Method
The main target-point of the study is surgical site infection (SSI), defined according to the Centers for Disease Control (CDC).	30 Days	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;