Optimal Care of Complicated Appendicitis
Study Details
Study Description
Brief 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
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appendectomy (removal of the appendix) right away
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appendectomy several weeks after the diagnosis
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This is a single center, prospective study to compare early appendectomy vs. non-operative management of immunocompetent patients with complicated appendicitis, and then to compare interval appendectomy vs. no interval appendectomy in those managed with the initial non-operative approach. Patients who choose early appendectomy will have surgery within 24 hours of diagnosis and be discharged once they are afebrile for 24 hours, have a normal WBC count, and can tolerate a diet. They will be discharged with 5 days of oral ciprofloxacin and metronidazole and follow-up in clinic 2-4 weeks later. Patients who choose non-operative management will receive piperacillin-tazobactam with or without abscess drainage until they are afebrile 24 hours with a normal WBC count and are tolerating a diet, followed by 5 days of oral ciprofloxacin and metronidazole upon discharge. These patients will then be seen in clinic in 2-4 weeks, at which time they will be given the choice of whether or not to undergo interval appendectomy at least 8 weeks from initial presentation. Those in the interval appendectomy group will follow-up one month post-operatively. Patients in both groups will be contacted 3 months and 2 years following initial presentation.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Early Appendectomy
|
Procedure: Early Appendectomy
Removal of the appendix within 24 hours of admission
Drug: Antibiotics
Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.
Other Names:
|
| Experimental: Interval Appendectomy
|
Procedure: Interval Appendectomy
Removal of the appendix after initial antibiotic treatment and at least 6 weeks of recovery.
Drug: Antibiotics
Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.
Other Names:
|
| Experimental: No Appendectomy
|
Drug: Antibiotics
Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Overall cost of care [2 years]
Total health care cost starting from time of admission
Secondary Outcome Measures
- Complications [2 years]
Number of persons who experience any of a number of specified complications, including new/recurrent abscess, wound infection, small bowel obstruction, or need for a more larger operation
- Time away from activity/parents away from work [2 years]
Time away from activity/parents away from work measured in days
- Duration of antibiotic therapy [2 years]
Duration of antibiotic therapy measured in days
- Length of stay [2 years]
Length of hospital all hospital stays measured in days
- Number of percutaneous drainage procedures [2 years]
Number of percutaneous drainage procedures
- Number of radiographic imaging studies [2 years]
Number of radiographic imaging studies including ultrasound, CT, and MRI
- Quality of life [2 years]
Quality of life measured by PedsQL 2 years following discharge
- Recurrent appendicitis [2 years]
Number of persons who experience recurrent appendicitis requiring hospitalization
Eligibility Criteria
Criteria
Inclusion criteria
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At least 1 of the following CT or MRI findings:
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Peri-appendicular abscess
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Extruded appendicolith
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Visible hole in appendiceal wall
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Free peritoneal air
OR
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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) *:
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White blood cell count (WBC) >15
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Peritonitis (involuntary right lower quadrant (RLQ) guarding, + Rovsing sign, percussion tenderness, and/or rebound tenderness)
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Temperature > 38.0 C *>90% specificity for complicated appendicitis based on unpublished institutional data
Exclusion Criteria
-
Immunocompromized state
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History of major abdominal operation
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Previous appendicitis
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Major comorbidities that preclude safe operation
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Inability to follow-up or appropriately consent
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Pregnant women
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Allergy to penicillin plus any one of the following:
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Hypersensitivity to ciprofloxacin and/or metronidazole
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Pregnant/lactating women
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Patients taking theophylline
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Patient taking tizanidine
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
Sponsors and Collaborators
- University of Michigan
Investigators
- Principal Investigator: Steven W. Bruch, M.D., University of Michigan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HUM00103791