Back to resultsComparison of Medical and Surgical Treatment of Uncomplicated Acute Appendicitis in Children
Primary Purpose
Appendicitis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Piperacillin/Tazobactam
Surgical Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Appendicitis
Eligibility Criteria
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.
Sites / Locations
- New York University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Medical Therapy
Surgical Intervention
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Readmission Rates
Percentage of patients readmitted to the hospital after discharge.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02991937
Brief Title
Comparison of Medical and Surgical Treatment of Uncomplicated Acute Appendicitis in Children
Official Title
Comparison of Medical and Surgical Treatment of Uncomplicated Acute Appendicitis in Children
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Medical Therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Surgical Intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Piperacillin/Tazobactam
Intervention Description
24 hours of IV antibiotic administration
Intervention Type
Procedure
Intervention Name(s)
Surgical Treatment
Other Intervention Name(s)
Appendectomy
Intervention Description
Appendectomy
Primary Outcome Measure Information:
Title
Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale - Parent
Description
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
Secondary Outcome Measure Information:
Title
Readmission Rates
Description
Percentage of patients readmitted to the hospital after discharge.
Time Frame
1 Year
Title
Incidence of Long-term Complications in Medical Therapy Group
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Fisher, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of Medical and Surgical Treatment of Uncomplicated Acute Appendicitis in Children
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