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

Sponsor

HaEmek Medical Center, Israel (Other)

Overall Status

Unknown status

CT.gov ID

NCT02404064

Collaborator

(none)

288

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Appendicitis	Drug: cefamezin 1g IV Drug: metronidazole 500 mg IV Drug: Placebo	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

288 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Mar 1, 2015

Anticipated Primary Completion Date :

Mar 1, 2015

Anticipated Study Completion Date :

Mar 1, 2017

Arms and Interventions

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

Arm

Intervention/Treatment

Other: Antibiotics perioperative

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

Drug: cefamezin 1g IV

perioperative antibiotics (Cefamizin 1g IV; )

Other Names:

Cefotaxime

Drug: metronidazole 500 mg IV

perioperative antibiotics (metronidazole 500 mg IV )

Other Names:

falgyl

Placebo Comparator: placebo - No Antibiotics perioperative

The intervention is No Antibiotics perioperative

Drug: Placebo

No perioperative antibiotics

Outcome Measures

Primary Outcome Measures

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;

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

HaEmek Medical Center, Israel

Investigators

Principal Investigator: Dan Hershko, Professor, haemek medical center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dan Hershko, Profesor, HaEmek Medical Center, Israel

ClinicalTrials.gov Identifier:

NCT02404064

Other Study ID Numbers:

134-14

First Posted:

Mar 31, 2015

Last Update Posted:

Mar 31, 2015

Last Verified:

Mar 1, 2015

Additional relevant MeSH terms:

Appendicitis

Metronidazole

Cefotaxime

Study Results

No Results Posted as of Mar 31, 2015