Appendicitis
Conditions
Keywords
Appendicitis, Non-operative, Children, Appendicolith, fecalith, Pediatrics
Brief summary
To determine if non-operative management with antibiotics alone is a feasible treatment alternative for pediatric patients with uncomplicated acute appendicitis with an appendicolith identified on imaging.
Detailed description
This study is a prospective randomized clinical trial comparing non-operative management with antibiotics to urgent appendectomy in children (ages 7-17yrs) with acute appendicitis with the presence of an appendicolith. Enrolled participants were followed up to 1 year post-discharge to observe the rates of appendicitis recurrence as well as identify the number of patients with complicated appendicitis as determined by pathologic examination.
Interventions
DRUGAntibiotics only (Zosyn then Augmentin)
Intravenous and oral antibiotics without surgery Piperacillin/Tazobactam and then Augmentin Cipro/Flagyl if Penicillin allergic
Sponsors
Peter Minneci
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Age : 7-17 years * Abdominal pain \</= 48hours prior to receiving antibiotics * White Blood Cell Count \>5 but \< 18 * US or CT confirmed early appendicitis plus: * US: \</=1.1 cm in diameter, presence of appendicolith * CT: \</= 1.1cm in diameter, presence of appendicolith
Exclusion criteria
* Positive urine pregnancy test * Pain \> 48 hours prior to first antibiotic dose * Diffuse peritonitis * History of chronic intermittent abdominal pain * White Blood Cell count ≤ 5 or ≥ 18 * Absence of appendicolith or any evidence on imaging studies concerning for evolving perforated appendicitis including abscess or phlegmon
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Did Not Have an Appendectomy | 1 year | Percentage of patients who were successfully managed nonoperatively with success defined as not undergoing appendectomy by one year after discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Complicated Appendicitis | 1 year | Percent of patients found to have complicated appendicitis (gangrenous or perforated) on pathologic examination. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Non-operative Non-operative management with antibiotics alone Zosyn (Piperacillin/Tazobactam) and then Augmentin unless penicillin allergic Cipro/Flagyl if penicillin allergic
Antibiotics only (Zosyn then Augmentin): Intravenous and oral antibiotics without surgery Piperacillin/Tazobactam and then Augmentin Cipro/Flagyl if Penicillin allergic | 5 |
| Surgery Usual care with urgent appendectomy | 9 |
| Total | 14 |
Baseline characteristics
| Characteristic | Surgery | Total | Non-operative |
|---|---|---|---|
| Age, Continuous | 11 years | 12 years | 14 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 12 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| 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 | 1 Participants | 4 Participants | 3 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 10 Participants | 2 Participants |
| Sex: Female, Male Female | 4 Participants | 8 Participants | 4 Participants |
| Sex: Female, Male Male | 5 Participants | 6 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 9 |
| other Total, other adverse events | 0 / 5 | 0 / 9 |
| serious Total, serious adverse events | 0 / 5 | 0 / 9 |
Outcome results
Primary
Number of Participants That Did Not Have an Appendectomy
Percentage of patients who were successfully managed nonoperatively with success defined as not undergoing appendectomy by one year after discharge
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Non-operative | Number of Participants That Did Not Have an Appendectomy | 2 Participants |
| Surgery | Number of Participants That Did Not Have an Appendectomy | 0 Participants |
Secondary
Number of Participants With Complicated Appendicitis
Percent of patients found to have complicated appendicitis (gangrenous or perforated) on pathologic examination.
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Non-operative | Number of Participants With Complicated Appendicitis | 0 Participants |
| Surgery | Number of Participants With Complicated Appendicitis | 6 Participants |