Complicated Appendicitis, Perforated Appendicitis
Conditions
Brief summary
This is a randomized study of patients 2-17 years old who are diagnosed with perforated appendicitis and develop an abscess after laparoscopy that is subsequently drained. Patients will be randomized to either receive an 8-day or a 4-day course of antibiotics. The aim of this study is to determine whether duration of antibiotic treatment at discharge demonstrates significant differences in clinical outcomes.
Detailed description
The central aim of this study is to determine whether duration of antibiotic treatment at discharge demonstrates significant differences in primary and secondary clinical outcomes. Specifically, this research aims to determine whether the readmission rate and length of stay for pediatric patients diagnosed with perforated appendicitis who form a post-laparoscopic abscess that is treated with percutaneous drainage and are treated with a 8-day oral antibiotic regimen at discharge is significantly different from those treated with a fixed 4-day regimen at discharge. This study includes patients ages 2-17 years old who present with perforated appendicitis-as diagnosed at laparoscopy and photographed as either a hole or as feces in the abdomen-and who develop an abscess after laparoscopy that is treated with percutaneous drainage. All post-laparoscopic abscess patients will receive the standard of care for antibiotic therapy at Phoenix Children's Hospital-IV ceftriaxone/metronidazole-until afebrile and tolerating food. All patients will be treated with the PCH standard of care and receive in-patient treatment for abscess until afebrile. At discharge, study patients will be randomly assigned to either an 8-day ampicillin/clavulanate regimen or a 4-day ampicillin/clavulanate regimen. Pediatric patients who are allergic to ampicillin will be excluded from the study. Patients will be followed thirty days post discharge to assess clinical outcomes.
Interventions
DRUGampicillin/clavulanate
FDA-approved antibiotic
Sponsors
Phoenix Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Age: 2 to 17 years of age * Diagnosis of perforated appendicitis at laparoscopy * Development of a post-appendectomy abscess that is treated with percutaneous drainage.
Exclusion criteria
* Patients who are allergic to ampicillin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Readmission Rate | 30 days | Rate of readmission to the hospital after abscess drainage. |
| Length of Hospital Stay | 30 days | How many days patient stays in the hospital if and when they are readmitted after their abscess drainage. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm A (8-day) In this study, all patients will be treated with the hospital standard of care and receive in-patient treatment for abscess until afebrile and tolerating food for 24 hours. After percutaneous drainage of the abscess, the patient will be randomly assigned to receive either an 8-day regimen (arm A) or a 4-day regimen (arm B) of antibiotics (Diagram 1). Patients will remain on IV ceftriaxone/metronidazole or other broad spectrum antibiotic equivalent until afebrile and tolerating food for 24 hours. Patients will complete their assigned 4- or 8-day regimen with oral ampicillin clavulanate or other broad spectrum antibiotic equivalent. If patients are not afebrile at the completion of their assigned regimen, prescribing an extended course of antibiotics is at the discretion of the treating surgeon. A prescribed oral course of antibiotics may be finished in the hospital or at home if patient is discharged. | 3 |
| Arm B (4-day) In this study, all patients will be treated with the hospital standard of care and receive in-patient treatment for abscess until afebrile and tolerating food for 24 hours. After percutaneous drainage of the abscess, the patient will be randomly assigned to receive either an 8-day regimen (arm A) or a 4-day regimen (arm B) of antibiotics (Diagram 1). Patients will remain on IV ceftriaxone/metronidazole or other broad spectrum antibiotic equivalent until afebrile and tolerating food for 24 hours. Patients will complete their assigned 4- or 8-day regimen with oral ampicillin clavulanate or other broad spectrum antibiotic equivalent. If patients are not afebrile at the completion of their assigned regimen, prescribing an extended course of antibiotics is at the discretion of the treating surgeon. A prescribed oral course of antibiotics may be finished in the hospital or at home if patient is discharged. | 4 |
| Total | 7 |
Baseline characteristics
| Characteristic | Arm A (8-day) | Total | Arm B (4-day) |
|---|---|---|---|
| Age, Continuous | 15.34 Years STANDARD_DEVIATION 2.48 | 12.09 Years STANDARD_DEVIATION 4.2 | 9.65 Years STANDARD_DEVIATION 3.56 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 2 Participants | 4 Participants | 2 Participants |
| Region of Enrollment United States | 3 participants | 7 participants | 4 participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Male | 2 Participants | 5 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 4 |
| other Total, other adverse events | 0 / 3 | 0 / 4 |
| serious Total, serious adverse events | 0 / 3 | 0 / 4 |
Outcome results
Primary
Hospital Readmission Rate
Rate of readmission to the hospital after abscess drainage.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A (8-Day) 30-day Readmission Rate | Hospital Readmission Rate | 0 Participants |
| Arm B (4-Day) 30-day Readmission Rate | Hospital Readmission Rate | 0 Participants |
Primary
Length of Hospital Stay
How many days patient stays in the hospital if and when they are readmitted after their abscess drainage.
Time frame: 30 days
Population: Participants were not readmitted to the hospital after abscess drainage.