Initial non-operative treatment strategy versus appendectomy treatment strategy for simple appendicitis in children aged 7-17 years old. APAC study

Completed

• Conditions: Appendicitis; inflamed appendix; 10017998

• Registration Number: NL-OMON54710
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024
• Study Completion: 2024-10-18

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 302

Inclusion Criteria

Eligible for inclusion are all children from 7 to 17 years old, inclusive, with
a radiologically confirmed simple appendicitis. Definition of simple
appendicitis is based upon predefined clinical, biochemical and radiological
(ultrasound) criteria.
Clinical & biochemical criteria:
- Unwell but not generally ill
- Localized tenderness in the right iliac fossa region
- Normal/hyperactive bowel sounds
- No guarding or palpable mass
- Biochemical signs of infection (Elevated White Blood Cell count (WBC) and/or
C-reactive protein (CRP)).
As recommended by the national guideline, all children with a clinical and/or
biochemical suspicion should undergo ultrasound studies. Ultrasound criteria to
confirm the diagnosis of acute simple appendicitis are:
- An incompressible, painful appendix with an outer diameter > 6 mm
- Secondary signs of inflammation such as surrounding fat infiltration, limited
clear free fluid surrounding the appendix, hyperemia within the appendiceal
wall.
- No fecolith, no signs of perforation, no signs of intra-abdominal abscess or
phlegmone.
In case the ultrasound is inconclusive, additional imaging studies may be
obtained. CT-scan is not recommended in the young children (due to its risk of
radiation induced malignancy). MRI is recommended in those places with
sufficient experience in the interpretation of the results. Only those in whom
imaging studies confirm the diagnosis of simple appendicitis can be included.
In case there is no certain diagnosis and a *watchful waiting* strategy is
chosen, the patient cannot be included.

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)
CRP 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)
• Fecolith (ultrasound)
• Serious co-morbidity
• Recurrent appendicitis
• Suspicion of an underlying malignancy or inflammatory bowel disease
• Documented type 1 allergy to the antibiotics used.

Study & Design

• Study Type: Interventional
• Study Design: Not specified