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NCT02687464 · ClinicalTrials.gov registry record · NA
Appendectomy Versus Non-Operative Treatment For Acute Non-Perforated Appendicitis in Children
A NA study, sponsored by Children's Mercy Hospital Kansas City.
- Completed
- Registry status
- NA
- Development phase
- 978
- Enrollment target
NCT02687464: Completed NA study, sponsored by Children's Mercy Hospital Kansas City.
NCT02687464 is a NA study that has completed, run by Children's Mercy Hospital Kansas City. The registered enrollment target is 978 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02687464, a NA study, has completed, sponsored by Children's Mercy Hospital Kansas City.
- COMPLETED
- Registry status
- NA
- Development phase
- 978 participants
- Enrollment target
Study Summary
Rationale and Aim: The standard treatment for acute appendicitis in children is appendectomy. An increasing body of evidence from the adult literature suggests that acute appendicitis may be treated effectively with antibiotics alone, avoiding the need for surgery. The aim of this study is to investigate the effectiveness of non-operative treatment of acute appendicitis in children. Study design: Pragmatic, parallel-group, unmasked, non-inferiority multicentre randomized controlled trial (RCT). Patient allocation: Children will be randomly allocated (age 5-16 years) with a diagnosis of acute appendicitis to either laparoscopic appendectomy or treatment with antibiotics. Randomization will be performed using stratification to ensure equal distribution between groups of presenting clinical and demographic features that may influence outcome including gender, duration of symptoms and center. Interventions: One group of children will undergo laparoscopic appendectomy that is the current standard treatment for children with acute appendicitis. The other group will be treated with intravenous antibiotics. A treatment pathway specifically designed for this study will be used. Primary Outcome: To be meaningful to parents of, and clinicians treating, children with acute appendicitis, the primary outcome is treatment failure defined as: (i) any additional intervention related to appendicitis requiring general anesthesia within 1 year of randomization (including recurrence of appendicitis after non-operative treatment, which we will treat with appendectomy) or (ii) negative appendectomy. Secondary outcomes are: (i) complications; (ii) time to discharge following randomization; (iii) number and duration of hospital admissions. Sample size and data analysis: The proposed RCT has a 20% non-inferiority margin to test the null hypothesis that treatment with antibiotics is inferior to appendectomy. Based on data from collaborating centers and a pilot study that we have performe
Primary Outcome
The primary outcome is treatment failure. Treatment failure is defined as: (i) additional intervention related to appendicitis requiring general anesthesia within 1 year of randomization (this includes the recurrence of appendicitis after non-operative treatment, which will be treated with appendectomy) or (ii) negative appendectomy. This definition of the primary outcome will capture all important parameters in both treatment groups including specifically: failure of antibiotic treatment requir
Interventions
- PROCEDURE Appendectomy
- OTHER Non-operative treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 978 participants |
| Start Date | 2016-01-20 |
| Est. Completion | 2023-03-02 |
| Phase | NA |
What the finished NCT02687464 record still lists
NCT02687464 is an interventional study that assigns participants to a tested intervention. The registered 978 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 2 interventions - of which Appendectomy is the first listed.
NCT02687464 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02687464 about?
NCT02687464 is a clinical study titled "Appendectomy Versus Non-Operative Treatment For Acute Non-Perforated Appendicitis in Children". Rationale and Aim: The standard treatment for acute appendicitis in children is appendectomy. An increasing body of evidence from the adult literature suggests that acute appendicitis may be treated effectively with antibiotics alone, avoiding the need for surgery. The aim of this study is to invest...
What is the current status of trial NCT02687464?
This trial is currently completed. It is a NA study. The enrollment target is 978 participants. The study started on 2016-01-20. Estimated completion is 2023-03-02.
What interventions are being tested in trial NCT02687464?
The interventions under investigation include: Appendectomy (PROCEDURE), Non-operative treatment (OTHER).
Who is sponsoring clinical trial NCT02687464?
This trial is sponsored by Children's Mercy Hospital Kansas City, which has 184 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02687464's enrollment target sits among peer trials
978 122nd of 2000 higher than 1,879 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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