The Management of Perforated Acute Appendicitis in Adult and Pediatric Populations

Description

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 Overview

Study Details

Study 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.

The Management of Perforated Acute Appendicitis: A Randomized Control Trial in the Adult and Pediatric Populations

The Management of Perforated Acute Appendicitis in Adult and Pediatric Populations

Condition
Perforated Appendicitis
Intervention / Treatment

-

Contacts and Locations

Huntington

Marshall University School of Medicine, Huntington, West Virginia, United States, 25701

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Marshall University,

Juan Sanabria, MD MSc FACS, PRINCIPAL_INVESTIGATOR, Marshall University School of Medicine

Study Record Dates

2023-11