drugset / Trial / NCT02848820
Initial Non-operative Treatment Strategy Versus Appendectomy Treatment Strategy for Simple Appendicitis in Children
Phase 4
Unknown
302 enrolled
Ramon Gorter
Amsterdam UMC, location VUmc · collabZonMw: The Netherlands Organisation for Health Research and Development · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
OBJECTIVE The aim of this study is to compare the effectiveness of initial non-operative treatment strategy (reserving appendectomy for those not responding or with recurrent disease) with immediate appendectomy in children from 7 to 17 years old, inclusive, with acute simple appendicitis in terms of complications, health-related QOL and costs. Main research question: What is the difference in proportion of patients experiencing complications within 1 year between both strategies in children from 7 to 17 years old, inclusive, with acute simple appendicitis?
Timeline
- Start
- 2016-12
- Primary completion
- 2024-12
- Completion
- 2024-12
Publications
- van Amstel P, Bachiri S, Knaapen M, van der Lee JH, van Eekelen R, Bemelman WA, Rippen-Wagner H, Bijlsma TS, Blanken-Peeters CFJM, Boerma EG, van den Boom AL, van den Broek FJC, Cense HA, van Duijvendijk P, Garssen FP, In 't Hof KH, Leijdekkers VJ, Lijkwan MA, Zijp GW, Heij HA, Derikx JPM, van Heurn ELW, Bakx R, Gorter RR; APAC collaborative study group. Non-operative treatment strategy versus surgery for children with simple appendicitis: non-inferiority randomised controlled trial. BMJ Med. 2026 May 13;5(1):e002466. doi: 10.1136/bmjmed-2025-002466. eCollection 2026.
- Knaapen M, van der Lee JH, Bakx R, The SL, van Heurn EWE, Heij HA, Gorter RR; APAC collaborative study group. Initial non-operative management of uncomplicated appendicitis in children: a protocol for a multicentre randomised controlled trial (APAC trial). BMJ Open. 2017 Nov 15;7(11):e018145. doi: 10.1136/bmjopen-2017-018145.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amoxicillin/clavulanic acid | Unknown | 25 mg | Intravenous |
| Subject | Amoxicillin/clavulanic acid | Unknown | 50 mg/kg | Intravenous |
| Subject | Gentamicin | Small molecule | 7 mg/kg | Intravenous |