Last updated on March 2018

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


Brief description of study

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?

Detailed Study Description

Initial non-operative treatment of acute simple appendicitis has recently been investigated in both the adult as the paediatric population. In the adult population, six Randomised Controlled Trial (RCTs) showed that an appendectomy could be avoided in 40-76% of the patients at the end of their follow-up period. Despite the fact that some patients need to undergo a delayed appendectomy, it has been demonstrated in systematic reviews that non-operative treatment strategy is associated with a significant reduction in complications, faster recovery and return to work, less pain duration and analgesic medication consumption. In children only pilot data is yet available. Short-term success rates of this strategy (including of the investigators own pilot cohort study) are between the 83-92%. Long-term results (one-year follow-up) are available from two studies; 62-75% did not require an appendectomy. No large RCT have yet been conducted in the paediatric population. It is therefore essential to generate high quality empirical evidence regarding this strategy in this subset of patients.

Clinical Study Identifier: NCT02848820

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Taco Bijlsma, MD PhD

Medical Center Alkmaar
Alkmaar, Netherlands
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Klaas in 't Hof, MD ...

Flevoziekenhuis
Almere, Netherlands
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Roel Bakx, MD PhD

AMC
Amsterdam, Netherlands
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Roel Bakx, MD PhD

VU University medical center
Amsterdam, Netherlands
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Hugo Bolhuis, MD

Gelre Hospital
Apeldoorn, Netherlands
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Huib Cense, MD PhD

Red Cross Hospital
Beverwijk, Netherlands
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J Jansen, MD PhD

Admiraal de Ruyter Hospital
Goes, Netherlands
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M Guijt, MD

Elkerliek hospital
Helmond, Netherlands
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Wim van Gemert, MD PhD

MUMC
Maastricht, Netherlands
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Peter Go, MD PhD

Antonius Hospital
Nieuwegein, Netherlands
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Ivo de Blaauw, MD PhD

Radboud UMC
Nijmegen, Netherlands
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Rene Wijnen, MD PhD

Erasmus MC
Rotterdam, Netherlands
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Caroline Hulsker, MD PhD

UMCU
Utrecht, Netherlands
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M Benders, MD PhD

Maxima medical center
Eindhoven, Netherlands
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