PEDIATRIC SURGERY RESEARCH COLLABORATIVE
Current Projects
Infant Perianal Abscess Quality Improvement Project
Currently enrolling patients
Perianal abscesses are very common in children under on year of age. These often recur and can be frustrating to treat for both families and caregivers. Current management may include incision and drainage, aspiration, observation, antibiotics, or a combination of these. There is no standard of care, and evidence-to-date is mixed with a wide range of reported recurrence rates from various methods of treatment. Our hypothesis is that implementation of a protocol for management of infant perianal abscesses that minimizes early surgical instrumentation will improve patient care, decreased time to abscess resolution and decreased use of surgical intervention.
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PI: Elizabeth Fialkowski
ENhancing Recovery In CHildrens Undergoing Surgery (ENRICH-US)
Currently enrolling patients
ENhancing Recovery In CHildrens Undergoing Surgery (ENRICH-US) 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.
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PI: Mehul Raval
Pilonidal Disease Study
Enrollment Completed; Data Analysis
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.
PI: Aaron Lipskar (https://clinicaltrials.gov/ct2/show/NCT03772873)
HIP Trial
("Hernia in Premies")
Enrollment Completed; Data Analysis
This is a multicenter randomized trial, funded by the NICHD, that seeks to determine the safest time for inguinal hernia repair in premature infants who are diagnosed with IH during their initial NICU hospital stay. The strategies compared are early IH repair (prior to NICU discharge) and later IH repair (after NICU discharge and when the infant is > 55 weeks postmenstrual age). The primary outcome is the occurrence of any serious adverse event (SAE) during a 10-month observation period. The primary analysis will compare the proportion of infants in each group with at least one SAE. The investigators hypothesized that 30% of infants in the early group compared to 20% of those in the later IH repair group would have at least one SAE. Secondary outcomes include the total number of hospital days during the study period and the mean cognitive composite scores on the Bayley Scales of Infant Development III in a subset of infants.
The trial was designed to incorporate as many PedSRC sites as possible and the PedSRC infrastructure was a prominent component of the NIH funding application (enhancing feasibility). The trial randomized 320 infants and was stopped after an interim analysis showed a 97% probability (Bayesian analysis) that later IH repair was associated with a lower proportion of infants with at least one SAE. Final analyses are being conducted presently.
ClinicalTrials.gov link https://clinicaltrials.gov/ct2/show/NCT01678638
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Appendicitis in the Time of COVID-19
Enrollment and analysis completed; Manuscript preparation
The COVID-19 pandemic has caused disruption in many areas of healthcare, including ion patients suffering from appendicitis, cancer, and trauma. In a single-center retrospective review of pediatric appendicitis patients treated at Children's Memorial Hermann Hospital, in Houston, TX, the rate of perforated appendicitis increased from 23.7% to 42.5%. Given differences in nationwide practice patterns among pediatric surgeons and changes in these patterns secondary to concerns of COVID-19, we aimed to characterize the treatment of pediatric patients with appendicitis, evaluate the severity of appendicitis during the COVID-19 pandemic, and patient outcomes during this time.