Appendicitis
Conditions
Keywords
General Surgery
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.
Interventions
PROCEDUREConservative Management
PROCEDUREOperative Management
Sponsors
Children's Hospital of Eastern Ontario
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Under 18 years of age * Perforated appendicitis where the treating physician chooses to follow the conservative approach rather than performing an immediate appendectomy
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Canada
Outcome results
None listed