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Identification of the optimal treatment strategy for complex appendicitis in the paediatric population: a protocol
Paul van Amstel1, Roel Bakx2, Johanna H van der Lee3,4
1Department of Pediatric Surgery, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam & Vrije Universiteit Amsterdam, Amsterdam, The Netherlands p.vanamstel@amsterdamumc.nl.
Insights
This study protocol outlines the CAPP study, comparing surgical versus non-operative treatments for complex appendicitis in children. The goal is to identify the optimal strategy for reducing complications and costs in pediatric appendicitis care.
Area of Science:
- Pediatric Surgery
- Gastrointestinal Surgery
- Clinical Trial Methodology
Background:
- Complex appendicitis in children presents treatment variability and high morbidity.
- Subtypes include appendicitis with and without appendiceal mass/abscess.
- Optimizing treatment strategies for pediatric complex appendicitis is crucial.
Purpose of the Study:
- To present the study protocol for the Complex Appendicitis in the Pediatric Population (CAPP) study.
- To compare treatment strategies for complex appendicitis in children.
- To identify the optimal approach for reducing complications and costs.
Main Methods:
- Nation-wide, multi-centre, comparative, non-randomised prospective cohort study.
- Includes children <18 years with imaging-confirmed complex appendicitis.
- Compares open vs. laparoscopic appendectomy (without mass/abscess) and non-operative vs. operative treatment (with mass/abscess).
- Aims for a sample size of 1308 patients over 2 years and 9 months.
- Primary outcome: proportion of patients with any complication at 3 months.
- Propensity score analysis will adjust for baseline differences.
Main Results:
- Study protocol presented, detailed methodology outlined.
- Primary and secondary outcomes defined for evaluating treatment efficacy.
- Statistical analysis plan includes propensity score methods to address bias.
Conclusions:
- The CAPP study protocol provides a framework for investigating optimal treatment for pediatric complex appendicitis.
- This research aims to reduce morbidity and healthcare costs associated with this condition.
- Findings will inform clinical practice and guidelines for managing complex appendicitis in children.
Introduction:
In daily practice large heterogeneity in the treatment of children with complex appendicitis exists. Complex appendicitis can be divided into two subtypes; complex appendicitis with and without appendiceal mass and/or abscess. As complex appendicitis is associated with high morbidity and costs, identification of the optimal treatment strategy is essential. In this article, we present the study protocol for the CAPP (Complex Appendicitis in the Pediatric Population) study.
Methods And Analysis:
This nation-wide, multi-centre, comparative, non-randomised prospective cohort study includes all children <18 years old with a preoperative suspicion of complex appendicitis, which is based on imaging confirmed acute appendicitis and predefined criteria regarding the severity of appendicitis. Eligible patients are recruited in more than 30 hospitals. Open appendectomy will be compared with laparoscopic appendectomy for children without appendiceal mass and/or abscess and initial non-operative treatment (ie, intravenous antibiotics with or without percutaneous drainage) to direct appendectomy for children with appendiceal mass and/or abscess. Based on historical data supplied by the participating hospitals and an inclusion period of 2 years and 9 months, a sample size of 1308 patients is aimed. Primary outcome is the proportion of patients experiencing any complication at 3 months follow-up. Reported complications will be assessed by an independent adjudication committee. Secondary outcomes include, but are not limited to, quality of life, and (in)direct costs. To adjust for baseline differences and selection bias, outcomes will be compared after propensity score analysis (inverse probability weighting and stratification).
Ethics And Dissemination:
The Medical Ethics Review Committee of the Amsterdam UMC, location AMC, declared that the Medical Research involving Human Subjects Act (WMO) did not apply to this study. Therefore, no official approval was required by national law. Study results will be presented in peer-reviewed scientific journals and at (inter)national conferences.
Trial Registration Numbers:
NCT04755179; NL9371.
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