Optimal Care of Complicated Appendicitis
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 5 - 17 |
| Updated: | 8/3/2018 |
| Start Date: | June 29, 2017 |
| End Date: | June 30, 2022 |
| Contact: | Sarah E. Fox, B.A. |
| Email: | sarasort@med.umich.edu |
| Phone: | 734-232-8005 |
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.
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.
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.
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.
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
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