Is Interval Appendectomy Necessary?
- Conditions
- Appendicitis
- Registration Number
- NCT01853683
- Lead Sponsor
- Children's Hospital of Eastern Ontario
- Brief Summary
Appendicitis is one of the most common surgical problems in children, with 20-35% of patients having perforated by the time they present to a doctor. In these cases, the patient is often treated non-surgically with antibiotics. Once a patient has improved, it is not known whether it is better to perform an interval appendectomy (IA) or to continue a watchful waiting approach. The purpose of this trial is to determine if expectant nonoperative management (watchful waiting) is not inferior compared to IA management after successful conservative treatment of appendiceal mass at admission.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
- Under 18 years of age
- Perforated appendicitis where the treating physician chooses to follow the conservative approach rather than performing an immediate appendectomy
- Uncertainty about the diagnosis
- The need for laparotomy/laparoscopy for another reason
- Perforated appendicitis with diffuse abdominal fluid on imaging associated with a clinical picture of severe sepsis
- Another medical condition that may affect the decision to operate e.g., inflammatory bowel disease
- A comorbidity or chronic illness that contraindicates the watchful waiting approach, e.g, diabetes or cardiac problems
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Recurrent appendicitis for the conservative group During a year of follow-up Operative complications for the operative group During a year of follow-up
- Secondary Outcome Measures
Name Time Method Duration of hospital stay This is the patients' original hospital stay, and re-admission for interval appendectomy when applicable, an expected average of 5 days
Related Research Topics
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Trial Locations
- Locations (1)
Children's Hospital of Eastern Ontario
🇨🇦Ottawa, Ontario, Canada
Children's Hospital of Eastern Ontario🇨🇦Ottawa, Ontario, Canada