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

doi:10.1016/j.cct.2019.06.013

. 2019 Aug:83:10-17.

doi: 10.1016/j.cct.2019.06.013. Epub 2019 Jun 26.

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

Peter C Minneci¹, Erinn M Hade², Amy E Lawrence³, Jacqueline M Saito⁴, Grace Z Mak⁵, Ronald B Hirschl⁶, Samir Gadepalli⁶, Michael A Helmrath⁷, Charles M Leys⁸, Thomas T Sato⁹, Dave R Lal⁹, Matthew P Landman¹⁰, Rashmi Kabre¹¹, Mary E Fallat¹², Beth A Fischer¹³, Jennifer N Cooper¹³, Katherine J Deans³; Midwest Pediatric Surgery Consortium

Affiliations

¹ Center for Surgical Outcomes Research, The Research Institute, Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, OH, USA; Department of Pediatric Surgery, Nationwide Children's Hospital, Columbus, OH, USA. Electronic address: peter.minneci@nationwidechildrens.org.
² Departments of Biomedical Informatics and Obstetrics & Gynecology, The Ohio State University College of Medicine, Columbus, OH, USA.
³ Center for Surgical Outcomes Research, The Research Institute, Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, OH, USA; Department of Pediatric Surgery, Nationwide Children's Hospital, Columbus, OH, USA.
⁴ Division of Pediatric Surgery, Department of Surgery, Washington University School of Medicine, St. Louis, MO, USA.
⁵ Section of Pediatric Surgery, Department of Surgery, The University of Chicago Medicine and Biologic Sciences, Chicago, IL, USA.
⁶ Division of Pediatric Surgery, Department of Surgery, University of Michigan School of Medicine, Ann Arbor, MI, USA.
⁷ Division of Pediatric Surgery, Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
⁸ Division of Pediatric Surgery, Department of Surgery, University of Wisconsin School of Medicine, Madison, WI, USA.
⁹ Division of Pediatric Surgery, Department of Surgery, Medical College of Wisconsin, Milwaukee, WI, USA.
¹⁰ Division of Pediatric Surgery, Department of Surgery, Indiana University School of Medicine, Indianapolis, IN, USA.
¹¹ Division of Pediatric Surgery, Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
¹² Division of Pediatric Surgery, Department of Surgery, University of Louisville School of Medicine, Louisville, KY, USA.
¹³ Center for Surgical Outcomes Research, The Research Institute, Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, OH, USA.

PMID: 31254670
PMCID: PMC7073001
DOI: 10.1016/j.cct.2019.06.013

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

Peter C Minneci et al. Contemp Clin Trials. 2019 Aug.

. 2019 Aug:83:10-17.

doi: 10.1016/j.cct.2019.06.013. Epub 2019 Jun 26.

Authors

Affiliations

¹ Center for Surgical Outcomes Research, The Research Institute, Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, OH, USA; Department of Pediatric Surgery, Nationwide Children's Hospital, Columbus, OH, USA. Electronic address: peter.minneci@nationwidechildrens.org.
² Departments of Biomedical Informatics and Obstetrics & Gynecology, The Ohio State University College of Medicine, Columbus, OH, USA.
³ Center for Surgical Outcomes Research, The Research Institute, Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, OH, USA; Department of Pediatric Surgery, Nationwide Children's Hospital, Columbus, OH, USA.
⁴ Division of Pediatric Surgery, Department of Surgery, Washington University School of Medicine, St. Louis, MO, USA.
⁵ Section of Pediatric Surgery, Department of Surgery, The University of Chicago Medicine and Biologic Sciences, Chicago, IL, USA.
⁶ Division of Pediatric Surgery, Department of Surgery, University of Michigan School of Medicine, Ann Arbor, MI, USA.
⁷ Division of Pediatric Surgery, Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
⁸ Division of Pediatric Surgery, Department of Surgery, University of Wisconsin School of Medicine, Madison, WI, USA.
⁹ Division of Pediatric Surgery, Department of Surgery, Medical College of Wisconsin, Milwaukee, WI, USA.
¹⁰ Division of Pediatric Surgery, Department of Surgery, Indiana University School of Medicine, Indianapolis, IN, USA.
¹¹ Division of Pediatric Surgery, Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
¹² Division of Pediatric Surgery, Department of Surgery, University of Louisville School of Medicine, Louisville, KY, USA.
¹³ Center for Surgical Outcomes Research, The Research Institute, Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, OH, USA.

PMID: 31254670
PMCID: PMC7073001
DOI: 10.1016/j.cct.2019.06.013

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.

Keywords: Antibiotics; Appendectomy; Appendicitis; Non-operative management; Patient choice trial.

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References

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1. Coran AG, Adzick NS, Caldamone AA, Krummel TM, Laberge JM, Shamberger RC, Pediatric Surgery, 7th edition, Elsevier Inc, Philadelphia, 2012.
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[1] McCaig LF, Burt CW, National Hospital Ambulatory Medical Care Survey: 1999 emergency department summary, Adv. Data 320 (2001) 1–34. - PubMed

[2] McCaig LF, Burt CW, National Hospital Ambulatory Medical Care Survey: 1999 emergency department summary, Adv. Data 320 (2001) 1–34. - PubMed

[3] Coran AG, Adzick NS, Caldamone AA, Krummel TM, Laberge JM, Shamberger RC, Pediatric Surgery, 7th edition, Elsevier Inc, Philadelphia, 2012.

[4] Coran AG, Adzick NS, Caldamone AA, Krummel TM, Laberge JM, Shamberger RC, Pediatric Surgery, 7th edition, Elsevier Inc, Philadelphia, 2012.

[5] Owings MFKL, Ambulatory and Inpatient Procedures in the United States, 1996, Hyattsville, National Center for Health Statistics, 1998. - PubMed

[6] Owings MFKL, Ambulatory and Inpatient Procedures in the United States, 1996, Hyattsville, National Center for Health Statistics, 1998. - PubMed

[7] Abes M, Petik B, Kazil S, Nonoperative treatment of acute appendicitis in children, J. Pediatr. Surg 42 (8) (2007) 1439–1442. - PubMed

[8] Abes M, Petik B, Kazil S, Nonoperative treatment of acute appendicitis in children, J. Pediatr. Surg 42 (8) (2007) 1439–1442. - PubMed

[9] Wilms IM, de Hoog DE, de Visser DC, Janzing HM, Appendectomy versus antibiotic treatment for acute appendicitis, Cochrane Database Syst. Rev 11 (2011) CD008359. - PubMed

[10] Wilms IM, de Hoog DE, de Visser DC, Janzing HM, Appendectomy versus antibiotic treatment for acute appendicitis, Cochrane Database Syst. Rev 11 (2011) CD008359. - PubMed

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

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

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