Clinical trial NCT03159754: Optimal Care of Complicated Appendicitis
Official title: Optimal Care of Complicated Appendicitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Appendicitis
Perforated Appendicitis
Ruptured Appendicitis
Complicated Appendicitis
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2017-05-19
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.}}}}

Eligibility criteria: 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

Primary outcomes:
measure: Overall Cost of Care
timeFrame: 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:
measure: Complications
timeFrame: During index/initial hospitalization (generally not more than 5-6 weeks)
measure: Parents Away From Work
timeFrame: During index/initial hospitalization (generally not more than 5-6 weeks)
measure: Duration of Antibiotic Therapy
timeFrame: During index/initial hospitalization (generally not more than 5-6 weeks)
measure: Length of Stay
timeFrame: During index/initial hospitalization (generally not more than 5-6 weeks)
measure: Number of Percutaneous Drainage Procedures
timeFrame: During index/initial hospitalization (generally not more than 5-6 weeks)
measure: Number of Radiographic Imaging Studies
timeFrame: During index/initial hospitalization (generally not more than 5-6 weeks)
measure: Quality of Life (PedsQL)
timeFrame: 1 month; for GI QOL; 2 years for Peds QL
measure: Recurrent Appendicitis
timeFrame: 2 years; (Although this appears longer than trial duration, study completion date is based on last 2 year survey turned in, and medical record analysis looked a full two years per participant which extended a bit longer.)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Steven W. Bruch, M.D.
role: PRINCIPAL_INVESTIGATOR
References: