Trial reportBMJ open2016
Acute uncomplicated appendicitis study: rationale and protocol for a multicentre, prospective randomised controlled non-inferiority study to evaluate the safety and effectiveness of non-operative management in children with acute uncomplicated appendicitis.
Trial report in BMJ open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02795793 (A Prospective Randomised Controlled Non-inferiority Study to Evaluate the Effectiveness and Safety), which is not on this map. Cited by 16 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Prospective Randomised Controlled Non-inferiority Study to Evaluate the Effectiveness and Safety (APRES) of Non-operative Management in Children With Acute Uncomplicated Appendicitis
Who cites it
16 citing papers in PubMed, 33 citations in OpenAlex.
- CONservative TReatment of Appendicitis in Children: a randomised controlled feasibility Trial (CONTRACT).Archives of disease in childhood · 2021Trial
- Conservative treatment for uncomplicated appendicitis in children: the CONTRACT feasibility study, including feasibility RCT.Health technology assessment (Winchester, England) · 2021Trial
- Clinical recovery in children with uncomplicated appendicitis undergoing non-operative treatment: secondary analysis of a prospective cohort study.European journal of pediatrics · 2019Trial
- Trial
- Adherence to General Medical Council guidance regarding disclosure of alternative treatments during the consent process.Annals of the Royal College of Surgeons of England · 2025Observational
- Assessing micro- vs macro-costing approaches for treating appendicitis in children with appendicectomy or non-operatively.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2023Article
- Observational
- The Management of Pediatric Acute Appendicitis-Survey among Pediatric Surgeons in Romania.Medicina (Kaunas, Lithuania) · 2022Article
- Parental Knowledge of Appendicitis and Preference for Operative or Non-Operative Treatment at a United Kingdom Children's Hospital.Children (Basel, Switzerland) · 2022Article
- Outcomes after appendectomy in children with acute appendicitis treated at a tertiary paediatric centre: results from a retrospective cohort study.Langenbeck's archives of surgery · 2021Article
- Nonoperative management of appendicitis in children.Translational gastroenterology and hepatology · 2021Review
- Management of complicated acute appendicitis in children: Still an existing controversy.World journal of gastrointestinal surgery · 2020Review
- Management of pediatric appendiceal carcinoid: a single institution experience from 5000 appendectomies.Pediatric surgery international · 2019Article
- Conservative treatment of acute appendicitis.Acta bio-medica : Atenei Parmensis · 2018Review
- Conservative therapy for appendicitis in children.Canadian family physician Medecin de famille canadien · 2018Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThis article presents an overview of a prospective randomised controlled non-inferiority study designed to evaluate the safety and effectiveness of non-operative management (NOM) with operative management in children with acute uncomplicated appendicitis (AUA). Here, we present the study protocol for this APRES study, a multicentre Australian study. The rationale and details of future analysis, in particular, non-inferiority calculations, cost-effectiveness, feasibility and acceptability of each intervention.
designA multicentre, prospective randomised controlled clinical trial, conducted in 2 Australian tertiary paediatric hospitals.
participantsChildren who meet the inclusion criteria of an age between 5 and 15 years and a clinical diagnosis of AUA will be invited to participate, and after consent will be randomised via a computer-based program into treatment groups. The study started in June 2016, and the target recruitment is 220 patients.
interventionsChildren in the control group will be treated with prophylactic antibiotics and appendicectomy, and those in the intervention group will be treated with antibiotic therapy alone. Primary outcome measures include unplanned or unnecessary operation and complications at 30 days. Secondary outcomes include longer term complications within 1 year, length of stay, time off work and school analgesic requirements and cost. ANALYSIS: Data analyses will be on the intention-to-treat principle using non-inferiority analysis. Analysis will include the Pearson χ ETHICS AND DISSEMINATION: The research has been approved by the Human Research Ethics Committee of the Sydney Children's Hospital Network. In addition, results will be reported through academic journals, seminars and conference presentations. TRIAL REGISTRATION NUMBERS: NCT02795793; ACTRN12616000788471.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.