Appendectomy Versus Non-Operative Treatment For Acute Non-Perforated Appendicitis in Children

Completed · Not applicable

Conditions studied: Appendicitis

In brief

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 performed, we expect recruitment of 978 children in total (90% power) over 19 months allowing for drop out. Follow-up will be for 12 months.

Key facts

Study ID: NCT02687464
Run by: Children's Mercy Hospital Kansas City
People needed: 978
Starts: 2016-01-20
Expected to finish: 2023-03-02
Last updated by the study team: 2023-12-26

Who can join

Age: 5 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

children (age 5-16 years)
clinical and /or radiological diagnosis (ultrasound [US] and/or CT scan) of acute non-perforated appendicitis
written informed parental/legal guardian permission in accordance with local regulations and institutional policy
written informed child assent or waiver in accordance with local regulations and institutional policy

You may not qualify if…

suspicion of perforated appendicitis
presentation with an appendix mass or phlegmon (on physical examination and/or imaging)
non-operative management (2 or more rounds of intravenous antibiotics) initiated at an outside institution
previous episode of appendicitis or appendix mass/phlegmon treated non-operatively
current treatment for malignancy
positive pregnancy test (if part of a clinical routine)
diagnosis of Cystic Fibrosis (CF)

Where it is running

Children's Mercy Kansas City — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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