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

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ClinicalTrials.gov Identifier: NCT02404064
Recruitment Status : Unknown
Verified March 2015 by Dan Hershko, HaEmek Medical Center, Israel.
Recruitment status was:  Not yet recruiting
First Posted : March 31, 2015
Last Update Posted : March 31, 2015
Sponsor:
Information provided by (Responsible Party):
Dan Hershko, HaEmek Medical Center, Israel

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 Not Applicable

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 .


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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 2015
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: Cefotaxime

Drug: metronidazole 500 mg IV
perioperative antibiotics (metronidazole 500 mg IV )
Other Name: falgyl

Placebo Comparator: placebo - No Antibiotics perioperative
The intervention is No Antibiotics perioperative
Drug: Placebo
No perioperative antibiotics




Primary Outcome Measures :
  1. The main target-point of the study is surgical site infection (SSI), defined according to the Centers for Disease Control (CDC). [ Time Frame: 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;




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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02404064


Contacts
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Contact: Dan Hershko, Professor 972+46494391 dan_he@clalit.org.il

Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
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Principal Investigator: Dan Hershko, Professor haemek medical center

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Responsible Party: Dan Hershko, Profesor, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT02404064     History of Changes
Other Study ID Numbers: 134-14
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: March 31, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents
Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Metronidazole
Cefazolin