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

NCT02404064 | Unknown

• 1 other identifier: 134-14
• Study Type: interventional
• Target: 288
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Appendicitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Antibiotics perioperative

OTHER

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

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

placebo - No Antibiotics perioperative

PLACEBO COMPARATOR

The intervention is No Antibiotics perioperative

Drug: Placebo

Interventions

cefamezin 1g IV DRUG

perioperative antibiotics (Cefamizin 1g IV; )

Also known as: Cefotaxime

Antibiotics perioperative

metronidazole 500 mg IV DRUG

perioperative antibiotics (metronidazole 500 mg IV )

Also known as: falgyl

Antibiotics perioperative

Placebo DRUG

No perioperative antibiotics

placebo - No Antibiotics perioperative

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Established diagnosis of acute appendicitis based on clinical examination, US and/or computed tomographic (CT) scan, and acute uncomplicated appendicitis at laparoscopic appendectomy.

You may not qualify if:

• 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

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

MeSH Terms

Conditions

Appendicitis

Interventions

Cefazolin; Cefotaxime; Metronidazole

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cephacetrile; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Dan Hershko, Professor

  haemek medical center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dan Hershko, Professor

CONTACT

972+46494391; dan_he@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesor

Study Record Dates

• First Submitted: March 15, 2015
• First Posted: March 31, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2017
• Last Updated: March 31, 2015

Record last verified: 2015-03