Status:
COMPLETED
Identification of the Optimal Treatment Strategy for Complex Appendicitis in the Pediatric Population
Lead Sponsor:
Ramon Gorter
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Amsterdam UMC, location VUmc
Conditions:
Appendicitis
Appendix Mass
Eligibility:
All Genders
Up to 17 years
Brief Summary
Aim of this study is to evaluate the effect of different treatment strategies on overall complications, health related-Quality of Life (hr-QOL) and costs among two subtypes of complex appendicitis in ...
Detailed Description
Up till now initiated research projects worldwide mainly focus on simple appendicitis (questioning the necessity of an appendectomy). However, complex appendicitis is associated with significant morbi...
Eligibility Criteria
Inclusion
- Eligible for inclusion are all children \<18 years old that need to undergo treatment for the suspicion of complex appendicitis. Suspicion of complex appendicitis is based upon the following predefined criteria:
- 4 or more points on our scoring system developed to predict complex appendicitis. The diagnostic accuracy of this scoring system is 91% (Range: 84-98%). This scoring system consists of five variables (clinical, biochemical and radiological,each awarded points). In case the total score is 4 or more points, the patient is likely to have complex appendicitis. Variables included in the scoring system are:
- Diffuse abdominal guarding (3 points)
- CRP level more than 38 mg/L (2 points)
- Signs on ultrasound / imaging indicative for complex appendicitis (2 points)
- More than one day abdominal pain (2 points)
- Temperature more than 37.5 degrees Celsius (1 point)
- Or
- High index of suspicion of complex appendicitis by the treating physician. If this is the case, the treating physician will make pre-treatment note upon what clinical, biochemical or radiological variable the high index of suspicion is based.
Exclusion
- Adult patients (=18 years old)
- Children with a suspicion of simple appendicitis (based upon the previous mentioned scoring system and radiological features)
Key Trial Info
Start Date :
August 12 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 3 2024
Estimated Enrollment :
1308 Patients enrolled
Trial Details
Trial ID
NCT04755179
Start Date
August 12 2019
End Date
July 3 2024
Last Update
July 30 2024
Active Locations (32)
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1
Northwest hospital group
Alkmaar, Netherlands
2
Flevoziekenhuis
Almere Stad, Netherlands
3
Meander MC
Amersfoort, Netherlands
4
Hospital Amstelland
Amstelveen, Netherlands