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

NCT02848820 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2023-10-23

No results posted yet for this study

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?

Conditions

  • Appendicitis

Interventions

DRUG

Augmentin + Gentamicin

Amoxicillin/clavulanic acid (Augmentin) 25/2.5mg 6-hourly (total 100/10 mg/kg daily; maximum 6000/600mg a day) intravenously for 48 hours Oral amoxicillin/clavulanic acid 50/12.5 mg/kg 8-hourly (max 1500/375mg a day) for in total 7 days Gentamicin 7mg/kg once daily for 48 hours

PROCEDURE

Appendectomy

Pre-, peri- and postoperative care according to local protocol. No routine postoperative antibiotics

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Amsterdam UMC, location VUmc

    collaborator OTHER

  • Ramon Gorter

    lead OTHER

Principal Investigators

  • Ernst van Heurn, MD PhD · Pediatric Surgical Center of Amsterdam (VUmc & AMC)

  • Ramon Gorter, MD · Pediatric Surgical Center of Amsterdam (VUmc & AMC)

  • Roel Bakx, MD PhD · Pediatric Surgical Center of Amsterdam (VUmc & AMC)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02848820 on ClinicalTrials.gov