NCT04253899

The Management of Perforated Acute Appendicitis in Adult and Pediatric Populations

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Marshall University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	Appendectomy	Interval Appendectomy
OTHER	Observation	observation and follow up

Timeline

• Start date: 2020-02-20
• Primary completion: 2023-11-01
• Completion: 2023-11-01
• First posted: 2020-02-05
• Last updated: 2023-04-04

Locations

1 site across 1 country: United States