The Management of Perforated Acute Appendicitis in Adult and Pediatric Populations

Perforated Appendicitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04253899
• Other study ID #: 1504002-3
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2020
• Est. completion date: November 2023

Study information

• Verified date: April 2023
• Source: Marshall University
• Contact: Juan Sanabria, MD MSc FACS
• Phone: 216 647 8399
• Email: sanabriaj[@]marshall.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Appendicitis
• Perforated Appendicitis

Intervention

Procedure:
• Appendectomy
Interval Appendectomy

Other:
• Observation
observation and follow up

Locations

Country	Name	City	State
United States	Marshall University School of Medicine	Huntington	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Marshall University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine rate and severity of complications after interval appendectomy		12 months
Primary	Determine the incidence and rate of appendectomies (in the observation arm) during the first year of diagnosis		12 months
Secondary	Determine the rate of complete response after percutaneous drainage and antibiotic therapy		12 months
Secondary	Determine the mean surgical value (quality/cost) for each group		12 months