The Management of Perforated Acute Appendicitis in Adult and Pediatric Populations

Not Applicable

Recruiting

• Conditions: Perforated Appendicitis
• Interventions: Other: Observation; Procedure: Appendectomy

• Registration Number: NCT04253899
• Lead Sponsor: Marshall University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-29
• Study First Submitted QC: 2020-01-31
• Study First Posted: 2020-02-05
• Study Start: 2020-02-20
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-03
• Last Update Posted: 2023-04-04
• Primary Completion: 2023-11
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental pediatric group:	Observation	patients ≤17 yo with acute perforated appendicitis abscess and observation (n=25)
Standard adult group:	Appendectomy	patients ≥18 yo with acute perforated appendicitis and interval appendectomy (n=25)
Standard pediatric group:	Appendectomy	patients ≤17 yo with acute perforated appendicitis and interval appendectomy (n=25)
Experimental adult group:	Observation	Patients ≥18 yo with acute perforated appendicitis and observation (n=25)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Marshall University School of Medicine; 🇺🇸 Huntington, West Virginia, United States