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
|Condition or disease||Intervention/treatment||Phase|
|Appendicitis||Drug: cefamezin 1g IV Drug: metronidazole 500 mg IV Drug: Placebo||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||288 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
No perioperative antibiotics
- 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;
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
|Contact: Dan Hershko, Professorfirstname.lastname@example.org|
|Principal Investigator:||Dan Hershko, Professor||haemek medical center|