Multi-institutional trial of non-operative management and surgery for uncomplicated appendicitis in children: Design and rationale
dc.contributor.author | Minneci, Peter C. | |
dc.contributor.author | Hade, Erinn M. | |
dc.contributor.author | Lawrence, Amy E. | |
dc.contributor.author | Saito, Jacqueline M. | |
dc.contributor.author | Mak, Grace Z. | |
dc.contributor.author | Hirschl, Ronald B. | |
dc.contributor.author | Gadepalli, Samir | |
dc.contributor.author | Helmrath, Michael A. | |
dc.contributor.author | Leys, Charles M. | |
dc.contributor.author | Sato, Thomas T. | |
dc.contributor.author | Lal, Dave R. | |
dc.contributor.author | Landman, Matthew P. | |
dc.contributor.author | Kabre, Rashmi | |
dc.contributor.author | Fallat, Mary E. | |
dc.contributor.author | Fischer, Beth A. | |
dc.contributor.author | Cooper, Jennifer N. | |
dc.contributor.author | Deans, Katherine J. | |
dc.contributor.department | Surgery, School of Medicine | en_US |
dc.date.accessioned | 2021-04-28T18:55:50Z | |
dc.date.available | 2021-04-28T18:55:50Z | |
dc.date.issued | 2019-08-01 | |
dc.description.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. | en_US |
dc.eprint.version | Author's manuscript | en_US |
dc.identifier.citation | Minneci, P. C., Hade, E. M., Lawrence, A. E., Saito, J. M., Mak, G. Z., Hirschl, R. B., Gadepalli, S., Helmrath, M. A., Leys, C. M., Sato, T. T., Lal, D. R., Landman, M. P., Kabre, R., Fallat, M. E., Fischer, B. A., Cooper, J. N., & Deans, K. J. (2019). Multi-institutional trial of non-operative management and surgery for uncomplicated appendicitis in children: Design and rationale. Contemporary Clinical Trials, 83, 10–17. https://doi.org/10.1016/j.cct.2019.06.013 | en_US |
dc.identifier.issn | 1551-7144 | en_US |
dc.identifier.uri | https://hdl.handle.net/1805/25791 | |
dc.language.iso | en_US | en_US |
dc.publisher | Elsevier | en_US |
dc.relation.isversionof | 10.1016/j.cct.2019.06.013 | en_US |
dc.relation.journal | Contemporary Clinical Trials | en_US |
dc.source | PMC | en_US |
dc.subject | Appendicitis | en_US |
dc.subject | Non-operative management | en_US |
dc.subject | Antibiotics | en_US |
dc.subject | Appendectomy | en_US |
dc.subject | Patient choice trial | en_US |
dc.title | Multi-institutional trial of non-operative management and surgery for uncomplicated appendicitis in children: Design and rationale | en_US |
dc.type | Article | en_US |
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