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Antibiotic Treatment Alone for Acute Simple Appendicitis in Children

NCT01356641 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-01-13

No results posted yet for this study

Summary

Appendectomy for acute appendicitis has recently been questioned as being the only correct treatment for appendicitis. Appendectomy has been reported to have significant early and late morbidity. This can be avoided with antibiotic treatment alone. Moreover, better quality of life and lower costs have been associated with antibiotic treatment alone. Five clinical trials in selected patients (males, older than 18 years) comparing appendectomy and antibiotic treatment alone as primary mode of treatment found that antibiotic treatment alone is safe and effective in 48-95% of the patients Conclusive evidence with regard to the efficacy of antibiotic treatment alone in children with proven acute appendicitis however is lacking. We propose a prospective cohort study to answer the following questions:

Conditions

  • Appendicitis

Interventions

DRUG

Antibiotic treatment alone

Amoxicillin/clavulanic acid 100/10 mg/kg 6-hourly Gentamicin 7 mg/kg once daily At least 48 hours intravenous administration, in total seven days of antibiotics Oral amoxicillin/clavulanic acid 50/12.5mg/kg

PROCEDURE

Appendectomy

Appendectomy either open or laparoscopic depending on the surgeon's preference

Sponsors & Collaborators

  • Red Cross Hospital Beverwijk

    collaborator OTHER

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    collaborator OTHER

  • St. Antonius Hospital

    collaborator OTHER

  • Flevoziekenhuis

    collaborator OTHER

  • Ramon R. Gorter

    lead OTHER

Principal Investigators

  • Ramon R Gorter, MD · Amsterdam UMC, location VUmc

  • Hugo A Heij, MD, PhD · Amsterdam UMC, location VUmc

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2017-01-31
Completion
2017-01-31

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 NCT01356641 on ClinicalTrials.gov