Appendicitis
Conditions
Brief summary
Several prior studies have demonstrated that medical management of acute appendicitis in adults is a safe first-line therapy option. This study aims to determine whether non-operative management of uncomplicated acute appendicitis with antibiotics is non-inferior to operative management in a pediatric population. This study will be a randomized controlled trial comparing non-operative management with antibiotics to surgical management of uncomplicated acute appendicitis. The hypothesis is that antibiotics are not worse than surgery for the treatment of uncomplicated appendicitis in children.
Interventions
DRUGPiperacillin/Tazobactam
24 hours of IV antibiotic administration
PROCEDURESurgical Treatment
Appendectomy
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* first episode of appendicitis * Pain \< 48 hours * White blood cell count \< 18,000 * temperature \< 103º F * radiographic evidence of acute appendicitis on ultrasound or CT without evidence of perforation * appendiceal diameter \< 11 mm * ability to take oral antibiotics
Exclusion criteria
* Prior antibiotic treatment for appendicitis * presence of medical condition prohibiting surgical therapy * radiographic or clinical evidence of abscess or perforation * appendiceal mass, positive pregnancy test * other diagnosis equally as likely as appendicitis * pain for ≥ 48 hours, white blood cell count ≥ 18,000, temperature ≥ 103º F, or appendiceal diameter ≥ 11 mm * inability to take oral antibiotics.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale - Parent | 1 Year | Brief, standardized, generic assessment instrument that systematically assesses patients' and parents' perceptions of health-related quality of life (HRQOL) in pediatric patients with chronic health conditions using pediatric cancer as an exemplary model. PedsQL consists of 23 items scored on a 5-point Likert scale (0=never to 4=almost always). Items are reversed scored and linearly transformed to a 0-100 scale (0=100, 1=75, 2=50, 3=25, and 4=0). The total score range is 0-100; the higher the score, the better the HRQOL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Readmission Rates | 1 Year | Percentage of patients readmitted to the hospital after discharge. |
| Incidence of Long-term Complications in Medical Therapy Group | 1 Year | Incidence of long-term complications will be reported as number of cases where appendicitis reoccurred resulting in appendectomies in participants of the medical therapy arm. This data will be obtained from medical record review. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Medical Therapy Subjects in the medical therapy arm will be treated with piperacillin/tazobactam for at least 24 hours. Ciprofloxacin/metronidazole will be used in penicillin-allergic patients. Subjects will be maintained on nothing by mouth with intravenous fluids for at least 12 hours. Subjects will be transitioned to oral antibiotics when their WBC is normal, they have a decrease in CRP by ≥ 15%, and they have been afebrile for 24 hours on IV antibiotics.
Piperacillin/Tazobactam: 24 hours of IV antibiotic administration | 20 |
| Surgical Intervention Subjects in the surgical treatment arm will receive intravenous antibiotics until the time of operation, and will be maintained on intravenous fluids and no oral intake until they undergo appendectomy as per standard of care. Appendectomy will occur within 24 hours of enrollment. Subjects in the surgical treatment arm will receive post-operative antibiotics as per standard of care.
Piperacillin/Tazobactam: 24 hours of IV antibiotic administration
Surgical Treatment: Appendectomy | 19 |
| Total | 39 |
Baseline characteristics
| Characteristic | Medical Therapy | Surgical Intervention | Total |
|---|---|---|---|
| Age, Continuous | 10.2 years | 9.7 years | 10 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 6 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 13 Participants | 27 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 | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 8 Participants | 15 Participants |
| Race (NIH/OMB) White | 11 Participants | 9 Participants | 20 Participants |
| Region of Enrollment United States | 20 participants | 19 participants | 39 participants |
| Sex: Female, Male Female | 7 Participants | 6 Participants | 13 Participants |
| Sex: Female, Male Male | 13 Participants | 13 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 19 |
| other Total, other adverse events | 8 / 20 | 0 / 19 |
| serious Total, serious adverse events | 0 / 20 | 0 / 19 |
Outcome results
Primary
Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale - Parent
Brief, standardized, generic assessment instrument that systematically assesses patients' and parents' perceptions of health-related quality of life (HRQOL) in pediatric patients with chronic health conditions using pediatric cancer as an exemplary model. PedsQL consists of 23 items scored on a 5-point Likert scale (0=never to 4=almost always). Items are reversed scored and linearly transformed to a 0-100 scale (0=100, 1=75, 2=50, 3=25, and 4=0). The total score range is 0-100; the higher the score, the better the HRQOL.
Time frame: 1 Year
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Medical Therapy | Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale - Parent | 91.3 score on a scale |
| Surgical Intervention | Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale - Parent | 90.2 score on a scale |
Secondary
Incidence of Long-term Complications in Medical Therapy Group
Incidence of long-term complications will be reported as number of cases where appendicitis reoccurred resulting in appendectomies in participants of the medical therapy arm. This data will be obtained from medical record review.
Time frame: 1 Year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medical Therapy | Incidence of Long-term Complications in Medical Therapy Group | 30 Number of cases in 20 participants |
Secondary
Readmission Rates
Percentage of patients readmitted to the hospital after discharge.
Time frame: 1 Year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medical Therapy | Readmission Rates | 25 percentage of participants |
| Surgical Intervention | Readmission Rates | 0 percentage of participants |