Initial Non-operative Treatment Strategy Versus Appendectomy Treatment Strategy for Simple Appendicitis in Children
Initial Non-operative Treatment Strategy Versus Appendectomy Treatment Strategy for Simple Appendicitis in Children
OBJECTIVE

 The aim of this study is to compare the effectiveness of initial non-operative treatment
 strategy (reserving appendectomy for those not responding or with recurrent disease) with
 immediate appendectomy in children from 7 to 17 years old, inclusive, with acute simple
 appendicitis in terms of complications, health-related QOL and costs.

 Main research question: What is the difference in proportion of patients experiencing
 complications within 1 year between both strategies in children from 7 to 17 years old,
 inclusive, with acute simple appendicitis?
Initial non-operative treatment of acute simple appendicitis has recently been investigated
 in both the adult as the paediatric population. In the adult population, six Randomised
 Controlled Trial (RCTs) showed that an appendectomy could be avoided in 40-76% of the
 patients at the end of their follow-up period. Despite the fact that some patients need to
 undergo a delayed appendectomy, it has been demonstrated in systematic reviews that
 non-operative treatment strategy is associated with a significant reduction in complications,
 faster recovery and return to work, less pain duration and analgesic medication consumption.
 In children only pilot data is yet available. Short-term success rates of this strategy
 (including of the investigators own pilot cohort study) are between the 83-92%. Long-term
 results (one-year follow-up) are available from two studies; 62-75% did not require an
 appendectomy. No large RCT have yet been conducted in the paediatric population. It is
 therefore essential to generate high quality empirical evidence regarding this strategy in
 this subset of patients.
Inclusion Criteria:

 -  Age 7-17 years

 -  Radiologically confirmed simple appendicitis, defined as:

 1. Clinical findings:

 -  Unwell, but not generally ill

 -  Localized tenderness in the right iliac fossa region

 -  Normal/hyperactive bowel sounds

 -  No guarding

 -  No mass palpable

 2. Ultrasonography:

 -  Incompressible appendix with an outer diameter of ≥6 mm

 -  Hyperaemia within the appendiceal wall

 -  Without faecolith

 -  Infiltration of surrounding fat

 -  No signs of perforation

 -  No signs of intra-abdominal abscess/phlegmon

 Exclusion Criteria:

 -  Generalized peritonitis, complex appendicitis or sepsis (based upon predefined
 criteria and scoring system).

 -  Scoring system: As scoring system was developed determining the risk of complex
 appendicitis based upon five pre-operative variable. Points have been awarded to each
 variable. In case the total score is less than 4 points, the patient is likely to have
 a simple appendicitis. In case the score is 4 or more points, the chance of having
 complex appendicitis is significant and those children will be excluded from this
 study. Variables:

 -  Diffuse abdominal guarding (3 points)

 -  C-Reactive Protein level more than 38 mg/L (2 points)

 -  Signs on ultrasound indicative of complex appendicitis (2 points)

 -  More than one day abdominal pain (2 points)

 -  Temperature: more than 37.5 degree Celsius (1 point)

 -  Faecolith (ultrasound)

 -  Serious co-morbidity

 -  Recurrent appendicitis

 -  Suspicion of an underlying malignancy or inflammatory bowel disease

 -  Documented type 1 allergy to the antibiotics used.