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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

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.

Condition or disease Intervention/treatment Phase
Appendicitis Drug: Piperacillin/Tazobactam Procedure: Surgical Treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Medical and Surgical Treatment of Uncomplicated Acute Appendicitis in Children
Actual Study Start Date : December 2016
Actual Primary Completion Date : December 1, 2020
Actual Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis

Arm Intervention/treatment
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.
Drug: Piperacillin/Tazobactam
24 hours of IV antibiotic administration

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.
Drug: Piperacillin/Tazobactam
24 hours of IV antibiotic administration

Procedure: Surgical Treatment
Appendectomy
Other Name: Appendectomy




Primary Outcome Measures :
  1. Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale Parent [ Time Frame: 1 Year ]
    Measurement model for the pediatric quality of life inventory.


Secondary Outcome Measures :
  1. 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.

  2. Immediate, 1-week, 2-week, 30-day, and 60-day success of non-operative management [ Time Frame: 60 Days ]
  3. Readmission rates for both groups [ Time Frame: 1 Year ]
  4. Long-term complications over one year [ Time Frame: 1 Year ]


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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02991937


Locations
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United States, New York
New York University
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Jason Fisher, MD NYU Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02991937    
Other Study ID Numbers: 16-00655
First Posted: December 14, 2016    Key Record Dates
Last Update Posted: December 30, 2020
Last Verified: December 2020

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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
Additional relevant MeSH terms:
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Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Tazobactam
Piperacillin
Piperacillin, Tazobactam Drug Combination
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action