NCT03159754

Optimal Care of Complicated Appendicitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

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.

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. {{{While 40 participants were enrolled as intended, and some data was collected from them, a combination of staff turnover and subsequent resource constraints did not permit the analysis originally intended. Thus, results data is shown comparing the early appendectomy participants against the other two arms combined.}}}}

Conditions

• Appendicitis
• Perforated Appendicitis
• Ruptured Appendicitis
• Complicated Appendicitis

Interventions

Type	Name	Description
PROCEDURE	Early Appendectomy	Removal of the appendix within 24 hours of admission
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.

Timeline

• Start date: 2017-06-29
• Primary completion: 2020-03-26
• Completion: 2020-03-26
• First posted: 2017-05-19
• Last updated: 2023-11-28
• Results posted: 2023-11-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study