Suppurative Appendicitis
Conditions
Keywords
Suppurative appendicitis, appendicitis, pediatric
Brief summary
The literature has reported that fast track surgery can be safely applied to children undergoing appendectomy for acute appendicitis. There is no current evidence regarding the application of same day discharge protocol in children with intra-operative findings of suppurative appendicitis. The current standard of care for patients who present with intra-operative findings of suppurative appendicitis includes post-operative admission and treatment with intravenous antibiotics. Patients are discharged home once they have met the following discharge criteria: temperature less than 38.5 degrees Celsius, pain control with oral pain medication, and tolerating a liquid diet. Given the evidence in the literature that has shown that same day discharge of patients with acute appendicitis is safe and effective, we propose that fast track surgery protocol can be safely applied to patients with intraoperative findings of suppurative appendicitis. We hypothesize that this will result in a decreased postoperative length of stay, without an increase in 30-day complication rate.
Interventions
OTHERPatients discharged home the same day following appendectomy
Patients are discharged to home on the same day following appendectomy with oral antibiotics.
Sponsors
Johns Hopkins All Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Pediatric patients aged 5-18 * Diagnosis of appendicitis and scheduled for appendectomy during the hours of 0600-1800. * Intraoperative findings of suppurative appendicitis
Exclusion criteria
* Pregnancy * Complex medical history not appropriate for same day discharge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post Operative Length of Stay | Post anesthesia care unit arrival to discharge home, an expected average of up to 48 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Thirty Day Complication Rate | Thirty days | Superficial wound infection, deep organ space infection, ileus or bowel obstruction requiring hospitalization or re-operation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fast Track Patients discharged home the same day following appendectomy
Patients discharged home the same day following appendectomy: Patients are discharged to home on the same day following appendectomy with oral antibiotics. | 18 |
| Admission Patients are admitted to the inpatient unit following appendectomy for suppurative appendicitis and treated per the current standard of care. | 18 |
| Total | 36 |
Baseline characteristics
| Characteristic | Admission | Fast Track | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 18 Participants | 18 Participants | 36 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 11.6 years STANDARD_DEVIATION 3.5 | 10.8 years STANDARD_DEVIATION 3.4 | 11.2 years STANDARD_DEVIATION 3.4 |
| Region of Enrollment United States | 18 participants | 18 participants | 36 participants |
| Sex: Female, Male Female | 5 Participants | 8 Participants | 13 Participants |
| Sex: Female, Male Male | 13 Participants | 10 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 18 | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 |
Outcome results
Primary
Post Operative Length of Stay
Time frame: Post anesthesia care unit arrival to discharge home, an expected average of up to 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fast Track | Post Operative Length of Stay | 8.2 Hours | Standard Deviation 18.7 |
| Admission | Post Operative Length of Stay | 23.4 Hours | Standard Deviation 4.2 |
Secondary
Thirty Day Complication Rate
Superficial wound infection, deep organ space infection, ileus or bowel obstruction requiring hospitalization or re-operation
Time frame: Thirty days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fast Track | Thirty Day Complication Rate | 2 participants |
| Admission | Thirty Day Complication Rate | 1 participants |