Clinical trial NCT04253899: The Management of Perforated Acute Appendicitis in Adult and Pediatric Populations
Official title: The Management of Perforated Acute Appendicitis: A Randomized Control Trial in the Adult and Pediatric Populations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Perforated Appendicitis
Keywords: Perforated appendicitis
Pediatric appendicitis
Appendectomy
Appendiceal abscess
Antibiotic Therapy
Lead sponsor: Marshall University
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Determine rate and severity of complications after interval appendectomy
timeFrame: 12 months
measure: Determine the incidence and rate of appendectomies (in the observation arm) during the first year of diagnosis
timeFrame: 12 months
Secondary outcomes:
measure: Determine the rate of complete response after percutaneous drainage and antibiotic therapy
timeFrame: 12 months
measure: Determine the mean surgical value (quality/cost) for each group
timeFrame: 12 months
Other outcomes:
Locations:
city: Huntington
country: United States
facility: Marshall University School of Medicine
state: West Virginia
Study officials:
affiliation: Marshall University School of Medicine
name: Juan Sanabria, MD MSc FACS
role: PRINCIPAL_INVESTIGATOR
References: