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

Appendicitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02404064
• Other study ID #: 134-14
• Status: Not yet recruiting
• Phase: N/A
• First received: March 15, 2015
• Last updated: March 26, 2015
• Start date: March 2015
• Est. completion date: March 2017

Study information

• Verified date: March 2015
• Source: HaEmek Medical Center, Israel
• Contact: Dan Hershko, Professor
• Phone: 972+46494391
• Email: dan_he[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 288
• Est. completion date: March 2017
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Appendicitis

Intervention

Drug:
• cefamezin 1g IV
perioperative antibiotics (Cefamizin 1g IV; )
• metronidazole 500 mg IV
perioperative antibiotics (metronidazole 500 mg IV )
• Placebo
No perioperative antibiotics

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No