PEDIATRIC SURGERY RESEARCH COLLABORATIVE

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Current Projects

Surgical Site Infection Study

Patient enrollment currently open

This study is a multiphase, multicenter mixed-methods study to develop and test an evidence-based bundle of interventions to prevent surgical site infection (SSI) in infants. The first phase of the project surveyed pediatric surgeons within the PedSRC regarding their current practices aimed at preventing SSI. A systematic review to determine the best evidence-based practices is currently underway. The next phase is a multicenter retrospective review of infants who underwent gastrointestinal surgery to determine: 1) the true incidence of SSI in this population, 2) the frequency in which SSI prevention practices are being used, and 3) risk factors associated with SSI development in this population. Concurrently, the bundle will be compiled based on the results of the systematic review using the Delphi Method. The final phase will be a pragmatic, randomized clinical trial to evaluate the effectiveness of the evidence-based bundle at reducing SSI in infants undergoing gastrointestinal surgery.

Pilonidal Study

Patient enrollment currently open

This study is a multi-center, non-randomized controlled trial. Pilonidal disease can be a frustrating condition, with a chronic and relapsing course. There is no clear optimal treatment. Minimally invasive pilonidal excision (MIPE) allows for a rapid return to activity following treatment, likely at a cost of higher recurrence. This is a prospective observational non-randomized clinical trial assessing different surgical treatments for pilonidal disease.  This trial allows for patient and/or surgeon to dictate the operation performed. Outcome measures, including need for second operative procedure, time to return to school/work, frequency of surgical complications, patient satisfaction and QOL will be captured. In addition, surgeon perspectives on the procedure will be studied. This study is registered on clinicaltrials.gov. (https://clinicaltrials.gov/ct2/show/NCT03772873)

Biliary Dyskinesia Study

Patient enrollment currently open

This study is an in-depth retrospective review of pediatric patients diagnosed with biliary dyskinesia who underwent a cholecystectomy. The focus is to capture data pertaining to patient characteristics at presentation (chief complaint, symptoms, physical examination findings, etc.), diagnostic work up, medical and surgical management, and outcomes following cholecystectomy. The goals of this study are two fold: 1) to assess the current variability in pediatric medical and surgical management for this diagnosis, and 2) to generate preliminary data to inform the design of a prospective observational trial to study the variability in patient presentation, methods of diagnosis, patterns of care, and outcomes in biliary dyskinesia patients. 

Link to Study Database

HIP Trial

Patient enrollment currently open

A randomized clinical trial to compare the overall safety of early versus late inguinal hernia repair in premature infants with respect to significant adverse events, total hospital days and neurodevelopmental outcome at 22-26 months corrected age.

Link to Study Database

CDH Guideline Study

Institutional enrollment currently open

The objective of this study is to identify institutions across an international spectrum of centers in first-world countries that care for infants with CDH that have a written clinical practice guideline (WCPG) specifically for the management of patients with CDH. These guidelines will be assessed and common elements identified. These common elements will guide the development of a common element-centered protocol, around which multi-institutional standardization can be initiated.

Ped ERAS Study

Currently in implementation phase

Enhanced Recovery After Surgery (ERAS) protocols have been found to decrease hospital length of stay, in-hospital costs, and complications for a wide variety of adult surgical populations.The objectives of this study are to demonstrate whether the implementation of a multi-faceted enhanced recovery protocol for children undergoing surgery for inflammatory bowel disease is feasible and safe as well as to assess the efficacy of the ERAS protocol by measuring clinical outcomes.

BAT Study

Initial study completed, validation study in development phase.

A prospective, observational, multi-institutional study of children following blunt abdominal trauma (BAT). The goal of this study is to develop a multivariable clinical prediction model (CPM) to calculate likelihood of intra-abdominal injury (IAI). Once validated, the CPM could be used to predict which patients are at low risk for clinically significant IAI and are, therefore, unlikely to benefit from a CT A/P.

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