Phase 4
Completed N=40
Optimal Care of Complicated Appendicitis
Acute Appendicitis · Perforated Appendicitis · Ruptured Appendicitis · Complicated Appendicitis
Source: ClinicalTrials.gov NCT03159754 ↗
Enrolled (actual)
40
Serious AEs
12.5%
Results posted
Nov 2023
Primary outcomePrimary: Overall Cost of Care
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 | — |
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
OR
- 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90% specificity for complicated appendicitis based on unpublished institutional data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
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. Informational only — not medical advice.