RECRUITING

The Management of Perforated Acute Appendicitis in Adult and Pediatric Populations

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2020-02-20
Study Completion:2023-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04253899

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.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and women of all ages.
  2. * Clinical and radiological diagnosis by contrast CT scan of acute perforated appendicitis.
  3. * Formal consent for the present study must be signed by the patient or his/her parents
  4. * Patients with initial presentation of a phlegmon (abscess in evolution)
  1. * Patients with non-perforated appendicitis
  2. * Presentation with initially non-perforated appendicitis but found perforation at surgery
  3. * Patient with septic shock
  4. * Patients who had previous appendectomy
  5. * Current treatment of malignancy
  6. * Immunocompromised patients
  7. * Positive pregnancy test
  8. * No consent for the study

Contacts and Locations

Study Contact

Juan Sanabria, MD MSc FACS
CONTACT
216 647 8399
sanabriaj@marshall.edu
Michael Abdelmasseh, MD
CONTACT
abdelmasseh@marshall.edu

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Marshall University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-02-20
Study Completion Date2023-11

Study Record Updates

Study Start Date2020-02-20
Study Completion Date2023-11

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Perforated Appendicitis