Optimal Care of Complicated Appendicitis

University of Michigan

Status and phase: Completed; Phase 4

Conditions: Appendicitis; Perforated Appendicitis; Complicated Appendicitis; Ruptured Appendicitis

Treatments: Drug: Antibiotics; Procedure: Interval Appendectomy; Procedure: Early Appendectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03159754

HUM00103791

Details and patient eligibility

About

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.

Full 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.}}}}

Enrollment: 40 patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 3 patient groups

Early Appendectomy

Experimental group

Treatment:

Procedure: Early Appendectomy

Drug: Antibiotics

Interval Appendectomy

Experimental group

Treatment:

Drug: Antibiotics

Procedure: Interval Appendectomy

No Appendectomy

Experimental group

Treatment:

Drug: Antibiotics