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

NCT02991937 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 16-00655
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Appendicitis

Outcome Measures

Primary Outcomes (1)

• 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.

  1 Year

Secondary Outcomes (2)

• Readmission Rates

  1 Year

• Incidence of Long-term Complications in Medical Therapy Group

  1 Year

Study Arms (2)

Medical Therapy

ACTIVE COMPARATOR

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

Surgical Intervention

ACTIVE COMPARATOR

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; Procedure: Surgical Treatment

Interventions

Piperacillin/Tazobactam DRUG

24 hours of IV antibiotic administration

Medical Therapy; Surgical Intervention

Surgical Treatment PROCEDURE

Appendectomy

Also known as: Appendectomy

Surgical Intervention

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Appendicitis

Interventions

Piperacillin, Tazobactam Drug Combination; Surgical Procedures, Operative; Appendectomy

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Tazobactam; Penicillanic Acid; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Piperacillin; Ampicillin; Penicillin G; Sulfur Compounds; Sulfones; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Digestive System Surgical Procedures

Results Point of Contact

• Title: Jason Fisher, MD
• Organization: NYU Langone Health

Jason.Fisher@nyulangone.org

212-263-7391

Study Officials

• Jason Fisher, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 14, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 21, 2022
• Results First Posted: January 21, 2022

Record last verified: 2021-12

Locations

US (1)