drugset / Trial / NCT02848820

Initial Non-operative Treatment Strategy Versus Appendectomy Treatment Strategy for Simple Appendicitis in Children

NCT02848820

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

Drugs

EvaluationDrugModalityDoseRoute
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

Indications