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

HaEmek Medical Center, Israel

Status: Unknown

Conditions: Appendicitis

Treatments: Drug: cefamezin 1g IV; Drug: metronidazole 500 mg IV; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02404064

134-14

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 288 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

288 participants in 2 patient groups, including a placebo group

Antibiotics perioperative

Other group

Description:

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

Treatment:

Drug: metronidazole 500 mg IV

Drug: cefamezin 1g IV

placebo - No Antibiotics perioperative

Placebo Comparator group

Description:

The intervention is No Antibiotics perioperative

Treatment:

Drug: Placebo