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

NCT ID: NCT02404064

Last Updated: 2015-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

288 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-03-31

Brief Summary

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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

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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 .

Conditions

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Appendicitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Antibiotics perioperative

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

Group Type OTHER

cefamezin 1g IV

Intervention Type DRUG

perioperative antibiotics (Cefamizin 1g IV; )

metronidazole 500 mg IV

Intervention Type DRUG

perioperative antibiotics (metronidazole 500 mg IV )

placebo - No Antibiotics perioperative

The intervention is No Antibiotics perioperative

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

No perioperative antibiotics

Interventions

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cefamezin 1g IV

perioperative antibiotics (Cefamizin 1g IV; )

Intervention Type DRUG

metronidazole 500 mg IV

perioperative antibiotics (metronidazole 500 mg IV )

Intervention Type DRUG

Placebo

No perioperative antibiotics

Intervention Type DRUG

Other Intervention Names

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Cefotaxime falgyl

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Responsible Party

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Dan Hershko

Profesor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dan Hershko, Professor

Role: PRINCIPAL_INVESTIGATOR

haemek medical center

Central Contacts

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Dan Hershko, Professor

Role: CONTACT

Phone: 972+46494391

Email: [email protected]

Other Identifiers

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134-14

Identifier Type: -

Identifier Source: org_study_id