Peter C Minneci1,2, Erinn M Hade3, Amy E Lawrence1,2, Yuri V Sebastião1, Jacqueline M Saito4, Grace Z Mak5, Christa Fox5, Ronald B Hirschl6, Samir Gadepalli6, Michael A Helmrath7, Jonathan E Kohler8, Charles M Leys8, Thomas T Sato9, Dave R Lal9, Matthew P Landman10, Rashmi Kabre11, Mary E Fallat12, Jennifer N Cooper1, Katherine J Deans1,2. 1. Center for Surgical Outcomes Research, Abigail Wexner Research Institute at Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, Ohio. 2. Department of Pediatric Surgery, Nationwide Children's Hospital, Columbus, Ohio. 3. Departments of Biomedical Informatics and Obstetrics & Gynecology, The Ohio State University College of Medicine, Columbus, Ohio. 4. Division of Pediatric Surgery, Department of Surgery, Washington University School of Medicine, St Louis, Missouri. 5. Section of Pediatric Surgery, Department of Surgery, University of Chicago Medicine and Biologic Sciences, Chicago, Illinois. 6. Division of Pediatric Surgery, Department of Surgery, University of Michigan School of Medicine, Ann Arbor. 7. Division of Pediatric Surgery, Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, Ohio. 8. Division of Pediatric Surgery, Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin. 9. Division of Pediatric Surgery, Department of Surgery, Medical College of Wisconsin, Milwaukee. 10. Division of Pediatric Surgery, Department of Surgery, Indiana University School of Medicine, Indianapolis. 11. Division of Pediatric Surgery, Ann & Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, Illinois. 12. Division of Pediatric Surgery, Department of Surgery, University of Louisville School of Medicine, Louisville, Kentucky.
Abstract
Importance: Nonoperative management with antibiotics alone has the potential to treat uncomplicated pediatric appendicitis with fewer disability days than surgery. Objective: To determine the success rate of nonoperative management and compare differences in treatment-related disability, satisfaction, health-related quality of life, and complications between nonoperative management and surgery in children with uncomplicated appendicitis. Design, Setting, and Participants: Multi-institutional nonrandomized controlled intervention study of 1068 children aged 7 through 17 years with uncomplicated appendicitis treated at 10 tertiary children's hospitals across 7 US states between May 2015 and October 2018 with 1-year follow-up through October 2019. Of the 1209 eligible patients approached, 1068 enrolled in the study. Interventions: Patient and family selection of nonoperative management with antibiotics alone (nonoperative group, n = 370) or urgent (≤12 hours of admission) laparoscopic appendectomy (surgery group, n = 698). Main Outcomes and Measures: The 2 primary outcomes assessed at 1 year were disability days, defined as the total number of days the child was not able to participate in all of his/her normal activities secondary to appendicitis-related care (expected difference, 5 days), and success rate of nonoperative management, defined as the proportion of patients initially managed nonoperatively who did not undergo appendectomy by 1 year (lowest acceptable success rate, ≥70%). Inverse probability of treatment weighting (IPTW) was used to adjust for differences between treatment groups for all outcome assessments. Results: Among 1068 patients who were enrolled (median age, 12.4 years; 38% girls), 370 (35%) chose nonoperative management and 698 (65%) chose surgery. A total of 806 (75%) had complete follow-up: 284 (77%) in the nonoperative group; 522 (75%) in the surgery group. Patients in the nonoperative group were more often younger (median age, 12.3 years vs 12.5 years), Black (9.6% vs 4.9%) or other race (14.6% vs 8.7%), had caregivers with a bachelor's degree (29.8% vs 23.5%), and underwent diagnostic ultrasound (79.7% vs 74.5%). After IPTW, the success rate of nonoperative management at 1 year was 67.1% (96% CI, 61.5%-72.31%; P = .86). Nonoperative management was associated with significantly fewer patient disability days at 1 year than did surgery (adjusted mean, 6.6 vs 10.9 days; mean difference, -4.3 days (99% CI, -6.17 to -2.43; P < .001). Of 16 other prespecified secondary end points, 10 showed no significant difference. Conclusion and Relevance: Among children with uncomplicated appendicitis, an initial nonoperative management strategy with antibiotics alone had a success rate of 67.1% and, compared with urgent surgery, was associated with statistically significantly fewer disability days at 1 year. However, there was substantial loss to follow-up, the comparison with the prespecified threshold for an acceptable success rate of nonoperative management was not statistically significant, and the hypothesized difference in disability days was not met. Trial Registration: ClinicalTrials.gov Identifier: NCT02271932.
Importance: Nonoperative management with antibiotics alone has the potential to treat uncomplicated pediatric appendicitis with fewer disability days than surgery. Objective: To determine the success rate of nonoperative management and compare differences in treatment-related disability, satisfaction, health-related quality of life, and complications between nonoperative management and surgery in children with uncomplicated appendicitis. Design, Setting, and Participants: Multi-institutional nonrandomized controlled intervention study of 1068 children aged 7 through 17 years with uncomplicated appendicitis treated at 10 tertiary children's hospitals across 7 US states between May 2015 and October 2018 with 1-year follow-up through October 2019. Of the 1209 eligible patients approached, 1068 enrolled in the study. Interventions: Patient and family selection of nonoperative management with antibiotics alone (nonoperative group, n = 370) or urgent (≤12 hours of admission) laparoscopic appendectomy (surgery group, n = 698). Main Outcomes and Measures: The 2 primary outcomes assessed at 1 year were disability days, defined as the total number of days the child was not able to participate in all of his/her normal activities secondary to appendicitis-related care (expected difference, 5 days), and success rate of nonoperative management, defined as the proportion of patients initially managed nonoperatively who did not undergo appendectomy by 1 year (lowest acceptable success rate, ≥70%). Inverse probability of treatment weighting (IPTW) was used to adjust for differences between treatment groups for all outcome assessments. Results: Among 1068 patients who were enrolled (median age, 12.4 years; 38% girls), 370 (35%) chose nonoperative management and 698 (65%) chose surgery. A total of 806 (75%) had complete follow-up: 284 (77%) in the nonoperative group; 522 (75%) in the surgery group. Patients in the nonoperative group were more often younger (median age, 12.3 years vs 12.5 years), Black (9.6% vs 4.9%) or other race (14.6% vs 8.7%), had caregivers with a bachelor's degree (29.8% vs 23.5%), and underwent diagnostic ultrasound (79.7% vs 74.5%). After IPTW, the success rate of nonoperative management at 1 year was 67.1% (96% CI, 61.5%-72.31%; P = .86). Nonoperative management was associated with significantly fewer patient disability days at 1 year than did surgery (adjusted mean, 6.6 vs 10.9 days; mean difference, -4.3 days (99% CI, -6.17 to -2.43; P < .001). Of 16 other prespecified secondary end points, 10 showed no significant difference. Conclusion and Relevance: Among children with uncomplicated appendicitis, an initial nonoperative management strategy with antibiotics alone had a success rate of 67.1% and, compared with urgent surgery, was associated with statistically significantly fewer disability days at 1 year. However, there was substantial loss to follow-up, the comparison with the prespecified threshold for an acceptable success rate of nonoperative management was not statistically significant, and the hypothesized difference in disability days was not met. Trial Registration: ClinicalTrials.gov Identifier: NCT02271932.
Authors: Peter C Minneci; Erinn M Hade; Gregory A Metzger; Jacqueline M Saito; Grace Z Mak; Katherine J Deans Journal: JAMA Date: 2021-06-22 Impact factor: 56.272
Authors: Suvi Sippola; Jussi Haijanen; Juha Grönroos; Tero Rautio; Pia Nordström; Tuomo Rantanen; Tarja Pinta; Imre Ilves; Anne Mattila; Jukka Rintala; Eliisa Löyttyniemi; Saija Hurme; Ville Tammilehto; Harri Marttila; Sanna Meriläinen; Johanna Laukkarinen; Eeva-Liisa Sävelä; Heini Savolainen; Tomi Sippola; Markku Aarnio; Hannu Paajanen; Paulina Salminen Journal: JAMA Date: 2021-01-26 Impact factor: 56.272
Authors: Paul van Amstel; Roel Bakx; Johanna H van der Lee; Marijke C van der Weide; Rik van Eekelen; Joep P M Derikx; Ernest L W van Heurn; Ramon R Gorter Journal: BMJ Open Date: 2022-02-17 Impact factor: 2.692
Authors: Peter C Minneci; Erinn M Hade; Lindsay A Gil; Gregory A Metzger; Jacqueline M Saito; Grace Z Mak; Ronald B Hirschl; Samir Gadepalli; Michael A Helmrath; Charles M Leys; Thomas T Sato; Dave R Lal; Matthew P Landman; Rashmi Kabre; Mary E Fallat; Jennifer N Cooper; Katherine J Deans Journal: JAMA Netw Open Date: 2022-05-02