The Management of Perforated Acute Appendicitis in Adult and Pediatric Populations

Overview

Patients admitted at Marshall Health – Cabell Huntington Hospital with the diagnosis of acute perforated appendicitis or appendicular abscess larger than 3cm will be admitted and treated with percutaneous drainage and the IV antibiotics for 3 days. If the patient becomes afebrile and has a normal WBC, the patient will stay in the hospital for a single day with oral antibiotics and then will be discharged to continue oral antibiotics for seven more days. If the patient is febrile or has elevated WBC either after the 3 days of IV antibiotics or the single day of oral antibiotics, the patient will complete a course of IV antibiotics for a total of seven days. If still febrile, the patient will undergo further assessment.

A follow up will be conducted ~10 days after discharge from the hospital to determine if the patient is still symptomatic or asymptomatic. Asymptomatic patients will be followed up every month for 3 months, while symptomatic patients will be treated as needed. After 12 weeks, subjects will be randomized to interval appendectomy vs observation. Follow-ups will occur every 3 months for 12 months, when the study will be concluded.

Full Title of Study: “The Management of Perforated Acute Appendicitis: A Randomized Control Trial in the Adult and Pediatric Populations”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2021

Interventions

  • Procedure: Appendectomy
    • Interval Appendectomy
  • Other: Observation
    • observation and follow up

Arms, Groups and Cohorts

  • Active Comparator: Standard pediatric group:
    • patients ≤17 yo with acute perforated appendicitis and interval appendectomy (n=25)
  • Experimental: Experimental pediatric group:
    • patients ≤17 yo with acute perforated appendicitis abscess and observation (n=25)
  • Active Comparator: Standard adult group:
    • patients ≥18 yo with acute perforated appendicitis and interval appendectomy (n=25)
  • Experimental: Experimental adult group:
    • Patients ≥18 yo with acute perforated appendicitis and observation (n=25)

Clinical Trial Outcome Measures

Primary Measures

  • Determine rate and severity of complications after interval appendectomy
    • Time Frame: 12 months
  • Determine the incidence and rate of appendectomies (in the observation arm) during the first year of diagnosis
    • Time Frame: 12 months

Secondary Measures

  • Determine the rate of complete response after percutaneous drainage and antibiotic therapy
    • Time Frame: 12 months
  • Determine the mean surgical value (quality/cost) for each group
    • Time Frame: 12 months

Participating in This Clinical Trial

Inclusion Criteria

  • Men and women of all ages.
  • Clinical and radiological diagnosis by contrast CT scan of acute perforated appendicitis.
  • Formal consent for the present study must be signed by the patient or his/her parents
  • Patients with initial presentation of a phlegmon (abscess in evolution)

Exclusion Criteria

  • Patients with non-perforated appendicitis
  • Presentation with initially non-perforated appendicitis but found perforation at surgery
  • Patient with septic shock
  • Patients who had previous appendectomy
  • Current treatment of malignancy
  • Immunocompromised patients
  • Positive pregnancy test
  • No consent for the study

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Marshall University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Juan Sanabria, Professor of Surgery – Marshall University
  • Overall Official(s)
    • Juan Sanabria, MD MSc FACS, Principal Investigator, Marshall University School of Medicine
  • Overall Contact(s)
    • Juan Sanabria, MD MSc FACS, 216 647 8399, sanabriaj@marshall.edu

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