Appendicitis
Conditions
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 .
Interventions
DRUGcefamezin 1g IV
perioperative antibiotics (Cefamizin 1g IV; )
DRUGmetronidazole 500 mg IV
perioperative antibiotics (metronidazole 500 mg IV )
DRUGPlacebo
No perioperative antibiotics
Sponsors
HaEmek Medical Center, Israel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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; |
Contacts
Primary ContactDan Hershko, Professor
Outcome results
None listed