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Multi-institutional trial of non-operative management and surgery for uncomplicated appendicitis in children: Design and rationale.

Abstract：

:Traditionally, children presenting with appendicitis are referred for urgent appendectomy. Recent improvements in the quality and availability of diagnostic imaging allow for better pre-operative characterization of appendicitis, including severity of inflammation; size of the appendix; and presence of extra-luminal inflammation, phlegmon, or abscess. These imaging advances, in conjunction with the availability of broad spectrum oral antibiotics, allow for the identification of a subset of patients with uncomplicated appendicitis that can be successfully treated with antibiotics alone. Recent studies demonstrated that antibiotics alone are a safe and efficacious treatment alternative for patents with uncomplicated appendicitis. The objective of this study is to perform a multi-institutional trial to examine the effectiveness of non-operative management of uncomplicated pediatric appendicitis across a group of large children's hospitals. A prospective patient choice design was chosen to compare non-operative management to surgery in order to assess effectiveness in a broad population representative of clinical practice in which non-operative management is offered as an alternative to surgery. The risks and benefits of each treatment are very different and a "successful" treatment depends on which risks and benefits are most important to each patient and his/her family. The patient-choice design allows for alignment of preferences with treatment. Patients meeting eligibility criteria are offered a choice of non-operative management or appendectomy. Primary outcomes include determining the success rate of non-operative management and comparing differences in disability days, and secondarily, complication rates, quality of life, and healthcare satisfaction, between patients choosing non-operative management and those choosing appendectomy.

journal_name

Contemp Clin Trials

journal_title

Contemporary clinical trials

authors

Minneci PC,Hade EM,Lawrence AE,Saito JM,Mak GZ,Hirschl RB,Gadepalli S,Helmrath MA,Leys CM,Sato TT,Lal DR,Landman MP,Kabre R,Fallat ME,Fischer BA,Cooper JN,Deans KJ,Midwest Pediatric Surgery Consortium.

doi

10.1016/j.cct.2019.06.013

subject

Has Abstract

pub_date

2019-08-01 00:00:00

pages

10-17

eissn

1551-7144

issn

1559-2030

pii

S1551-7144(19)30126-0

journal_volume

83

pub_type

杂志文章

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