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Comparison of Medical and Surgical Treatment of Uncomplicated Acute Appendicitis in Children

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ClinicalTrials.gov Identifier: NCT02991937
Recruitment Status : Completed
First Posted : December 14, 2016
Last Update Posted : December 30, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date  ICMJE December 5, 2016
First Posted Date  ICMJE December 14, 2016
Last Update Posted Date December 30, 2020
Actual Study Start Date  ICMJE December 2016
Actual Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2016)
Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale Parent [ Time Frame: 1 Year ]
Measurement model for the pediatric quality of life inventory.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2016)
  • Child scores on the PedsQL [ Time Frame: 1 Year ]
    Brief, standardized, generic assessment instrument that systematically assesses patients' and parents' perceptions of HRQOL in pediatric patients with chronic health conditions using pediatric cancer as an exemplary model.
  • Immediate, 1-week, 2-week, 30-day, and 60-day success of non-operative management [ Time Frame: 60 Days ]
  • Readmission rates for both groups [ Time Frame: 1 Year ]
  • Long-term complications over one year [ Time Frame: 1 Year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Medical and Surgical Treatment of Uncomplicated Acute Appendicitis in Children
Official Title  ICMJE Comparison of Medical and Surgical Treatment of Uncomplicated Acute Appendicitis in Children
Brief Summary This is a randomized controlled trial of 190 subjects 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. The primary outcome will be survey scores on the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale Parent-proxy report. Secondary outcomes will include child scores on the PedsQL; length of stay; immediate, 1-week, 2-week, 30-day, and 60-day success of non-operative management; readmission rates for both groups; and long-term complications over one year.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Appendicitis
Intervention  ICMJE
  • Drug: Piperacillin/Tazobactam
    24 hours of IV antibiotic administration
  • Procedure: Surgical Treatment
    Appendectomy
    Other Name: Appendectomy
Study Arms  ICMJE
  • Active Comparator: 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.
    Intervention: Drug: Piperacillin/Tazobactam
  • Active Comparator: 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.
    Interventions:
    • Drug: Piperacillin/Tazobactam
    • Procedure: Surgical Treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 28, 2020)
39
Original Estimated Enrollment  ICMJE
 (submitted: December 9, 2016)
190
Actual Study Completion Date  ICMJE December 1, 2020
Actual Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02991937
Other Study ID Numbers  ICMJE 16-00655
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jason Fisher, MD NYU Langone Health
PRS Account NYU Langone Health
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP