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

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

302

Participants

Timeline

Start Date

December 31, 2016

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2024

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

Trial Locations (15)

Unknown

Medical Center Alkmaar, Alkmaar

Flevoziekenhuis, Almere Stad

Amstelland, Amstelveen

AMC, Amsterdam

OLVG, Amsterdam

VU University medical center, Amsterdam

Gelre Hospital, Apeldoorn

Rijnstate, Arnhem

Red Cross Hospital, Beverwijk

Albert Schweitzer, Dordrecht

Maxima medical center, Eindhoven

Zuyderland, Heerlen

Antonius Hospital, Nieuwegein

Franciscus, Gasthuis en Vlietland, Rotterdam

Haga ziekenhuis, The Hague

All Listed Sponsors
collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

collaborator

Amsterdam UMC, location VUmc

OTHER

lead

Ramon Gorter

OTHER

NCT02848820 - Initial Non-operative Treatment Strategy Versus Appendectomy Treatment Strategy for Simple Appendicitis in Children | Biotech Hunter | Biotech Hunter