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NCT Number: NCT02991937

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

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.

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Key information

Conditions

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

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

New York University

New York, 10016, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Piperacillin/tazobactam

Drug

24 hours of IV antibiotic administration

surgical treatment

Procedure

Appendectomy

Other names: Appendectomy

Primary outcomes

  1. Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale - Parent

    Time frame: 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 outcomes

  1. Readmission Rates

    Time frame: 1 Year

    Percentage of patients readmitted to the hospital after discharge.

  2. Incidence of Long-term Complications in Medical Therapy Group

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Dec 14, 2016
Registry last updated
Jan 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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