Clinical Trial: Intravenous Versus Intravenous/Oral Antibiotics for Perforated Appendicitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Intravenous Versus Intravenous/Oral Antibiotics for Perforated Appendicitis
Brief Summary:
The objective of this study is to scientifically evaluate two different management strategies for perforated appendicitis.
The hypothesis is that early discharge with oral antibiotic therapy may result in a dramatic decrease in medical care expenses for the patient.
The primary outcome variable between the two strategies is abscess rate.
Detailed Summary:
This will be a single institution, prospective, randomized clinical trial involving patients who present to the hospital with perforated appendicitis. This will be a definitive study.
Power calculation was based on abscess rate in the previous prospective, randomized study we just finished. Our current rate is 18%, or just under one-fifth of the patients. A doubling of this rate to 36% would place just over one third of the patients at risk which would be unacceptable. Using a delta of 0.18 with alpha of 0.05 and power of 0.8, the sample size is 74 patients in each arm. Therefore we will anticipate enrolling 150.
Subjects will be those children who undergo a laparoscopic appendectomy as part of their routine care.
Perforation will be defined as an identifiable hole in the appendix or stool in the abdomen.
The control group will receive current standard care: ceftriaxone 50mg/kg once a day (maximum dose = 2 grams) and metronidazole 30mg/kg once a day (maximum dose = 1 gram) with once a day dosing for both. The length of antibiotic therapy will be a minimum of 5 days. At that time, if they have been afebrile for at least 24 hours, a white blood cell (WBC) count will be obtained, and if that is within normal limits, the antibiotics will be discontinued and the patient will be discharged. If the WBC is elevated, they will receive another 2 days before recheck, if still elevated, they receive another 3 days and a CT is obtained. If, after 5 days of therapy, the patient remains febrile, therapy will continue until afebrile before a WBC check is performed. This is all our current standard management.
The experimental group will receive the same combination of antibiotics while in th
Sponsor: Children's Mercy Hospital Kansas City
Current Primary Outcome: Abscess After Appendectomy [ Time Frame: 1 month ]
Original Primary Outcome: Abscess After Appendectomy
Current Secondary Outcome: Length of Stay, Charges, Adverse Events [ Time Frame: 1 month ]
Original Secondary Outcome: Length of Stay, Charges, Adverse Events
Information By: Children's Mercy Hospital Kansas City
Dates:
Date Received: April 16, 2007
Date Started: March 2007
Date Completion:
Last Updated: December 12, 2011
Last Verified: December 2011
