Current Studies
Collaborative research in action—improving surgical care, one study at a time.
The Midwest Pediatric Surgery Research Consortium is currently conducting multi-institutional studies focused on high-impact pediatric surgical conditions. These active projects bring together the expertise of our 11 member hospitals to generate meaningful data, improve outcomes, and guide best practices in the surgical care of children.
Esophageal Atresia/Tracheoesophageal Fistula
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Esophageal Atresia/Tracheoesophageal Fistula (EA/TEF) occurs in approximately 1/3500 live births. The MWPSC Centers identified variability in surgical techniques and management of infants with EA/TEF due to the lack of evidence-based guidelines. This was the first disease studied with the consortium. In 2016, Lal et al. published the largest multi-institutional retrospective analysis of 396 patients to define and understand current management practices. Their findings included an overall postoperative complication rate of 62%, anastomotic stricture rate of 42% and substantial practice variability amongst the participating centers.
In 2017, Lal et al. expanded on the previous study and examined specific peri-operative management features in patients with type-c defects, searching for modifiable factors associated with the high complication rates found in their previous study. It was shocking to the authors that the overall complication rates for patients with EA/TEF had not improved in decades, despite advances in technology and surgical technique. The authors reported the use of trans-anastomotic tubes in the post-operative setting were associated with increased rates of anastomotic stricture (OR 2.2, p=0.01), interposing prosthetic material between the trachea and esophageal suture line was associated with higher anastomotic leak rates (OR 4.7, p<0.001). Furthermore, common practices such as the use of prophylactic antibiotics greater than 24 hours or empiric acid suppression did not prevent complications. Lastly, obtaining post-operative esophagrams on day 5 instead of the traditional day 7, was safe and resulted in earlier initiation of feedings.
The identified risk factors in the 2017 paper, led to the creation of evidence-based clinical practice guidelines to standardize management amongst institutions within the consortium. The outcomes from this intervention were published in a 2020 paper by Bence et al. A standard management bundle was applied to 102 infants with type c-defects and compared to a historical control of 68 infants. The key components of the management bundle were no prosthetic material between esophageal and tracheal sutures, no routine trans-anastomotic tube, no prophylactic antibiotics past 24 hours, and performing esophagrams within 5 postoperative days. The authors demonstrated no increase in complications keeping prophylactic antibiotics to only 24 hours and performing an esophogram at day 5 instead of day 7 from surgery. Additionally, when compliance to the no prosthetic material and no trans-anastomotic tube was >80% there was a reduction in anastomotic strictures.
Two other special populations of EA/TEF have been studied through the MWPSC: patients with right-sided aortic arch (RAA), and those with type E (H-type) TEF. Lal et al. reported findings from one of the largest studies on neonates with EA and RAA. When compared to infants with EA and a left aortic arch, infants with EA and a RAA were more severely ill with lower birth weight and higher rates of prematurity and complex congenital heart disease. They found that EA repair in infants with RAA can be safely repaired through a right or left thoracotomy. However, there was a trend to higher anastomotic strictures in RAA patients who underwent EA repair via a right thoracotomy. From the initial study on perioperative outcomes in EA patients, a high rate of vocal cord paralysis/paresis (5-28%) was identified and varied by EA/TEF type. This data led to a subsequent MWPSC proof of concept study by Wright et al. in which intraoperative nerve monitoring was used to identify, stimulate and preserve the recurrent laryngeal nerve during fistula ligation in infants with Type E (H-type) TEF. EA/TEF remains an active area of research amongst the consortium. The goal is to improve the care and outcomes of infants undergoing EA/TEF repair through evidence-based practices and standardization of care.
Nonoperative Management of Uncomplicated Appendicitis
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Appendicitis remains the most common pediatric surgical emergency, and treatment with an appendectomy in children has been largely unchallenged. Recently there have been several studies showing the safety and efficacy of non-operative management with antibiotics alone, however, prospective large multi-institutional studies in children were lacking. In 2019 Minneci et al. published their study design and in 2020 they published their findings comparing operative vs. non-operative management of pediatric uncomplicated appendicitis. Across the participating centers, 1068 patients were enrolled in the study. Of those, 65% of patients and families chose surgery and 35% chose antibiotics alone. Of patients that chose not to have surgery, 63% were successful at 1 year of follow-up, and they had significantly fewer disability days (6.6 vs. 10.9) with similar quality of life and satisfaction scores. This showed the safety and efficacy of nonoperative management, challenging the traditional dogma, and has given providers and patients the information required to have informed discussions on the treatment approach.
The follow-up from this study is ongoing with active research and grant funding to continue studying the management of acute appendicitis within our consortium. We have been fortunate to partner with the Patient-Centered Outcomes Research Institute for project funding.
Sources
Minneci PC, Hade EM, Lawrence AE, Saito JM, Mak GZ, Hirschl RB, et al. Multi-institutional trial of non-operative management and surgery for uncomplicated appendicitis in children: Design and rationale. Contemporary Clinical Trials 2019;83:10–7. https://doi.org/10.1016/j.cct.2019.06.013.
Minneci PC, Hade EM, Lawrence AE, Sebastião YV, Saito JM, Mak GZ, et al. Association of Nonoperative Management Using Antibiotic Therapy vs Laparoscopic Appendectomy With Treatment Success and Disability Days in Children With Uncomplicated Appendicitis. JAMA 2020;324:581. https://doi.org/10.1001/jama.2020.10888.
Minneci PC, Hade EM, Metzger GA, Saito JM, Mak GZ, Deans KJ, et al. Association of Initial Treatment With Antibiotics vs Surgery With Treatment Success and Disability in Subgroups of Children With Uncomplicated Appendicitis. JAMA 2021;325:2502–4. https://doi.org/10.1001/jama.2021.6710.
Thyroid Disease
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Both benign and malignant thyroid disease occurs in the pediatric population. As with many other pediatric diseases, the incidence is rare and difficult to study in a single institution. Therefore, most recommendations and guidelines on medical and surgical management of pediatric thyroid disease are founded on adult-based evidence. Through the MWPSC, Bruch et al. are studying all aspects of pediatric thyroid disease. The initial workup and evaluation, imaging, surgical intervention and complications, adjuvant radioactive iodine, and follow-up are being studied from patients across the consortium. This will provide the first multi-institutional evidence-based guidelines that are pediatric-specific. They also plan to continue this prospectively as the largest known pediatric thyroid registry.