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Initial non-operative management of uncomplicated appendicitis in children: a protocol for a multicentre randomised
Max Knaapen1, Johanna H van der Lee2, Roel Bakx1
1Pediatric Surgical Center of Amsterdam, Emma Children's Hospital AMC and VU University Medical Center, Amsterdam, The Netherlands.
Insights
This study protocol outlines the APAC trial, comparing antibiotics versus primary appendectomy for simple appendicitis in children. It aims to determine the effectiveness and quality of life outcomes for non-operative treatment in pediatric appendicitis.
Area of Science:
- Pediatric Surgery
- Gastroenterology
- Clinical Trials
Background:
- Appendicitis is increasingly recognized as not always a progressive disease, with simple and complicated forms distinguished.
- Non-operative treatment (NOT) for simple appendicitis in children has shown promise in small studies but requires robust evidence.
- Effectiveness and quality of life (QoL) impact of NOT versus appendectomy in pediatric simple appendicitis remain to be established.
Purpose of the Study:
- To provide the study protocol for the Antibiotics versus Primary Appendectomy in Children (APAC) trial.
- To compare the effectiveness and QoL outcomes of NOT versus appendectomy for simple appendicitis in children.
- To establish evidence for the safety and efficacy of non-operative management in pediatric appendicitis.
Main Methods:
- A multicenter, non-inferiority, randomized controlled trial involving children aged 7-17 years with imaging-confirmed simple appendicitis.
- Randomization between appendectomy and NOT (intravenous antibiotics followed by oral antibiotics if criteria met).
- Primary outcome: rate of complications at 1-year follow-up. Secondary outcomes: delayed appendectomies, QoL, pain, and costs.
Main Results:
- This section presents the study protocol; results are pending.
- The trial is registered (NCT02848820; NTR5977) and has received ethical approval.
- Data monitoring and safety oversight are in place, with results intended for publication.
Conclusions:
- The APAC trial protocol is established to rigorously evaluate non-operative management for simple appendicitis in children.
- Findings will inform clinical decision-making regarding the optimal treatment strategy for pediatric simple appendicitis.
- The study aims to provide high-quality evidence on complications, effectiveness, and quality of life.
Introduction:
Based on epidemiological, immunological and pathology data, the idea that appendicitis is not necessarily a progressive disease is gaining ground. Two types are distinguished: simple and complicated appendicitis. Non-operative treatment (NOT) of children with simple appendicitis has been investigated in several small studies. So far, it is deemed safe. However, its effectiveness and effect on quality of life (QoL) have yet to be established in an adequately powered randomised trial. In this article, we provide the study protocol for the APAC (Antibiotics versus Primary Appendectomy in Children) trial.
Methods And Analysis:
This multicentre, non-inferiority, randomised controlled trial randomises children aged 7-17 years with imaging-confirmed simple appendicitis between appendectomy and NOT. Patients are recruited in 15 hospitals. The intended sample size, based on the primary outcome, rate of complications and a non-inferiority margin of 5%, is 334 patients.NOT consists of intravenous antibiotics for 48-72 hours, daily blood tests and ultrasound follow-up. If the patient meets the predefined discharge criteria, antibiotic treatment is continued orally at home. Primary outcome is the rate of complications at 1-year follow-up. An independent adjudication committee will assess all complications and their relation to the allocated treatment. Secondary outcomes include, but are not limited to, delayed appendectomies, QoL, pain and (in)direct costs.The primary outcome will be analysed both according to the intention-to-treat principle and the per-protocol principle, and is presented with a one-sided 97.5% CI. We will use multiple logistic and linear regression for binary and continuous outcomes, respectively, to adjust for stratification factors.
Ethics And Dissemination:
The protocol has been approved by the Medical Ethics Review Committee of the Academic Medical Center, Amsterdam. Data monitoring is performed by an independent institute and a Data Safety Monitoring Board has been assigned. Results will be presented in peer-reviewed academic journals and at (international) conferences.
Trial Registration Number:
NCT02848820; NTR5977; Pre-results.
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