Optimal Care of Complicated Appendicitis

University of Michigan40 enrolled

Overview

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.

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.}}}}

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

Eligibility

Sex: ALLMin age: 5 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Overall Cost of Care

Total health care cost starting from time of admission was the intention of this outcome measure. However, the institutions potentially involved were unwilling to provide access to any cost data so this could not be analyzed for any length of time.

Time frame: The original intention was to gather cost data for 2 years per person following admission. As no cost data was able to be procured, there is no time frame to which it applies.

Secondary Outcomes

Complications

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 larger operation