Overview

Optimal Care of Complicated Appendicitis

Status:
Active, not recruiting
Trial end date:
2022-06-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Michigan
Treatments:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Ciprofloxacin
Metronidazole
Piperacillin
Piperacillin, Tazobactam Drug Combination
Tazobactam
Criteria
Inclusion criteria

1. At least 1 of the following CT or MRI findings:

1. Peri-appendicular abscess

2. Extruded appendicolith

3. Visible hole in appendiceal wall

4. Free peritoneal air

OR

2. 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) *:

1. White blood cell count (WBC) >15

2. Peritonitis (involuntary right lower quadrant (RLQ) guarding, + Rovsing sign,
percussion tenderness, and/or rebound tenderness)

3. Temperature > 38.0 C *>90% specificity for complicated appendicitis based on
unpublished institutional data

Exclusion Criteria

1. Immunocompromized state

2. History of major abdominal operation

3. Previous appendicitis

4. Major comorbidities that preclude safe operation

5. Inability to follow-up or appropriately consent

6. Pregnant women

7. Allergy to penicillin plus any one of the following:

1. Hypersensitivity to ciprofloxacin and/or metronidazole

2. Pregnant/lactating women

3. Patients taking theophylline

4. Patient taking tizanidine