Phase 4 N=40 Treatment

Optimal Care of Complicated Appendicitis

Appendicitis · Perforated Appendicitis · Ruptured Appendicitis · Complicated Appendicitis

Bottom Line

View on ClinicalTrials.gov: NCT03159754 ↗

Enrolled (actual)

Serious AEs

12.5%

Results posted

Nov 2023

Primary outcome: Primary: Overall Cost of Care

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Early Appendectomy (Procedure); Interval Appendectomy (Procedure); Antibiotics (Drug)
Age: Pediatric · 5+ yrs
Sex: All
Sponsor: University of Michigan
Primary completion: Mar 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Cost of Care	—	—
SECONDARY Complications	9; 6; 1	—
SECONDARY Parents Away From Work	7.6; 9.3; 3.5	—
SECONDARY Duration of Antibiotic Therapy	6.3; 5.1; 5.4	—
SECONDARY Length of Stay	7.8; 7.4; 3.5	—
SECONDARY Number of Percutaneous Drainage Procedures	4; 4; 1; 1; 0; 0	—
SECONDARY Number of Radiographic Imaging Studies	1.96; 2.04; 1.88	—
SECONDARY Quality of Life (PedsQL)	80.18; 88.4; 87.25; 86.3; 87.34	—
SECONDARY Recurrent Appendicitis	2; 0	—

Summary

When the appendix becomes infected and inflamed, it is called appendicitis. Sometimes, if the infection and inflammation get worse, the appendix can die or burst, leading to a larger infection or even pus pockets around the appendix. This is called complicated, or perforated, appendicitis. Three common treatments for complicated appendicitis are * appendectomy (removal of the appendix) right away * appendectomy several weeks after the diagnosis * treating the appendicitis without performing an appendectomy This study seeks to determine which of these three approaches is most cost-effective in children with complicated appendicitis.

Eligibility Criteria

Inclusion criteria

At least 1 of the following CT or MRI findings:
Peri-appendicular abscess
Extruded appendicolith
Visible hole in appendiceal wall
Free peritoneal air

CT or MRI read with phlegmon or diffuse/extensive inflammation/free fluid plus 1 of 3 of the following (with CT) or 2 of 3 of the following (with MRI) *:
White blood cell count (WBC) >15
Peritonitis (involuntary right lower quadrant (RLQ) guarding, + Rovsing sign, percussion tenderness, and/or rebound tenderness)
Temperature > 38.0 C *>90% specificity for complicated appendicitis based on unpublished institutional data

Exclusion Criteria

Immunocompromized state
History of major abdominal operation
Previous appendicitis
Major comorbidities that preclude safe operation
Inability to follow-up or appropriately consent
Pregnant women
Allergy to penicillin plus any one of the following:
Hypersensitivity to ciprofloxacin and/or metronidazole
Pregnant/lactating women
Patients taking theophylline
Patient taking tizanidine

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03159754). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.