The Management of Perforated Acute Appendicitis in Adult and Pediatric Populations

NCT04253899 — Not applicable, Unknown, 100 participants, Marshall University

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

Registry	NCT04253899
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	100 (Estimated)
Sponsor	Marshall University (Other)
Conditions	Perforated Appendicitis
Interventions	Appendectomy, Observation (Procedure, other)
Dates	start 2020-02-20, primary completion 2023-11-01 (estimated), completion 2023-11-01 (estimated), first posted 2020-02-05, last updated 2023-04-04
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Standard pediatric group:	Active comparator	Procedure: Appendectomy	patients ≤17 yo with acute perforated appendicitis and interval appendectomy (n=25)
Experimental pediatric group:	Experimental	Other: Observation	patients ≤17 yo with acute perforated appendicitis abscess and observation (n=25)
Standard adult group:	Active comparator	Procedure: Appendectomy	patients ≥18 yo with acute perforated appendicitis and interval appendectomy (n=25)
Experimental adult group:	Experimental	Other: Observation	Patients ≥18 yo with acute perforated appendicitis and observation (n=25)

Appendectomy (Procedure): Interval Appendectomy
Observation (Other): observation and follow up

+Outcome measures

Primary outcomes

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

Secondary outcomes

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]

+Eligibility

Sex: All

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

+Locations (1)

Facility	City	Country	Status
Marshall University School of Medicine	Huntington, West Virginia	United States	Recruiting

+Investigators

Juan Sanabria, MD MSc FACS, Principal investigator, Marshall University School of Medicine