Recruiting

Observational Study

Sponsor:

Marshall University

Code:

NCT04253899

Conditions

Perforated Appendicitis

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Appendectomy

Observation

Study Details

Brief summary:

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.

Conditions

Perforated Appendicitis

Study ID

NCT04253899

Start date

Feb 20, 2020

Status verified date

Apr, 2023

Completion date

Nov, 2023

Anticipated

Primary completion date

Nov, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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)

Interventions

Appendectomy

Interval Appendectomy

Observation

observation and follow up

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Juan Sanabria, MD MSc FACS

216 647 8399sanabriaj@marshall.edu

Michael Abdelmasseh, MD

abdelmasseh@marshall.edu

Locations

Marshall University School of Medicine

Recruiting

Huntington, West Virginia, United States, 25701

Contacts

Juan Sanabria, MD MSc FACS

216-647-8399sanabriaj@marshall.edu

More Information

Sponsor

Marshall University

Last update posted

Apr 4, 2023

Last verified

Apr, 2023

Keywords

  • Perforated appendicitis
  • Pediatric appendicitis
  • Appendectomy
  • Appendiceal abscess
  • Antibiotic Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Marshall University on 2023-04-04.