Clinical trial NCT00462020: Intravenous Versus Intravenous/Oral Antibiotics for Perforated Appendicitis
Official title: Intravenous Versus Intravenous/Oral Antibiotics for Perforated Appendicitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perforated Appendicitis
Keywords: appendicitis, perforation, abscess, treatment
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2007-04-18
Enrollment: 102
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: 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 Scan 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 the hospital. When the patient is tolerating a regular diet, on oral pain medication and has been afebrile for over 12 hours, they will be discharged on oral antibiotics to complete a course of 7 days. The home antibiotic regimen will be ampicillin/clavulanic acid (Augmentin®). Augmentin® dose will be 40mg/kg twice a day. They will be asked to bring their pill containers with them to clinic where we will quantify medication compliance.

Given the purpose of this study is the comparison of oral antibiotics to intravenous antibiotics, an allergy to one of the above medications will not be considered an exclusion criteria. In such cases the patient will be treated with an alternative that offers the same spectrum of coverage, but will be included in the study.

Eligibility criteria: Inclusion Criteria:

* Identifiable hole in the appendix or stool in the abdomen at the time of appendectomy

Exclusion Criteria:

* Known immune deficiency
* Abscess identified on pre-op imaging
* Another condition affecting surgical decision making or recovery (e.g. hemophilia, severe cardiac or respiratory co-morbidities).

Primary outcomes:
measure: Abscess After Appendectomy
timeFrame: 1 month
Secondary outcomes:
measure: Operative Time
timeFrame: 1 month
measure: Time to Regular Diet
timeFrame: 1 month
measure: Length of Stay After Operation
timeFrame: 1 month
measure: Total Healthcare Visits
timeFrame: 1 month
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Shawn D St. Peter
role: PRINCIPAL_INVESTIGATOR
References: