Clinical Trial: Optimal Care of Complicated Appendicitis
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Optimal Care of Complicated Appendicitis
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
- 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 Summary: 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.
Sponsor: University of Michigan
Current Primary Outcome: Overall cost of care [ Time Frame: 2 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Complications [ Time Frame: 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 [ Time Frame: 2 years ]Time away from activity/parents away from work measured in days
- Duration of antibiotic therapy [ Time Frame: 2 years ]Duration of antibiotic therapy measured in days
- Length of stay [ Time Frame: 2 years ]Length of hospital all hospital stays measured in days
- Number of percutaneous drainage procedures [ Time Frame: 2 years ]Number of percutaneous drainage procedures
- Number of radiographic imaging studies [ Time Frame: 2 years ]Number of radiographic imaging studies including ultrasound, CT, and MRI
- Quality of life [ Time Frame: 2 years ]Quality of life measured by PedsQL 2 years following discharge
- Recurrent appendicitis [ Time Frame: 2 years ]Number of persons who experience recurrent appendicitis requiring hospitalization
Original Secondary Outcome: Same as current
Information By: University of Michigan
Dates:
Date Received: May 17, 2017
Date Started: June 30, 2017
Date Completion: June 30, 2022
Last Updated: May 17, 2017
Last Verified: May 2017