Multi-Institutional Cohort Study of Pilonidal Disease Management
prosthetic material between the trachea and esophageal suture lines was associated with an increased leak rate. This retrospective review also demonstrated that esophagrams could be safely performed on post-operative day 5 as opposed to the traditional day 7, with no increased leak rate or delayed leaks in the early esophagram cohort. Infants obtaining early esophagrams began oral feeding sooner and this is likely to translate to decreased oral aversion and hospital stay. Peri-operative prophylactic antibiotic administration beyond 24 hours was a common finding in our study. The duration of peri-operative prophylactic antibiotics has been targeted throughout surgery as a metric of quality of care and our study demonstrated that prolongation of antibiotics for greater than 24 hours has no therapeutic benefit.
Our prospective multi-institutional study will track patients with esophageal atresia from birth, through surgical repair, hospitalization and include long-term follow-up. Members of the MWPSC will standardize care and utilize an evidence-based, consensus peri-operative management pathway for EA repair. This care bundle will: 1) exclude the use of trans-anastomotic tubes; 2) exclude the use of prosthetic material at the esophageal anastomosis; 3) limit postoperative prophylactic antimicrobial agents to less than or equal to 24 hours in the absence of infection; 4) obtain esophagrams at postoperative day 5; and 5) discourage/limit the use of acid suppression medications.
Due to the lack of evidence based guidelines, there is large variability in surgical techniques and management of infants with esophageal atresia (EA). This variability in care likely has profound impacts on outcomes as well as costs. The first step in decreasing variation was to perform a retrospective review of EA patients and identify variation in care within the 11 participating institutions. This review confirmed wide variation in management amongst the members of the MWPSC and also identified variables associated with complications. For example, the use of post-operative trans-anastomotic tubes were associated with anastomotic strictures and interposing
Retrospective Assessment of Congenital Lung Lesions
Management of Spontaneous Pneumothorax
Evaluation of Current Postoperative Opioid Prescribing, Use, and Disposal in Pediatric Patients
Esophageal atresia/Tracheoesophageal fistula
Primary spontaneous pneumothorax (PSP) refers to accumulation of air in the chest cavity between the lung and the chest wall, resulting in collapse of the lung, occurring in a patient without known lung disease or injury. This occurs most commonly in adolescents and young adults, and is often related to cysts on the lung, or blebs, that rupture and leak air. Some pediatric surgeons have started to utilize simple aspiration for initial management of PSP, despite a historical preference for the chest tube placement approach in children. However, very few children have been included in the existing studies of simple aspiration (4), and it is well recognized that adult data should not simply be extrapolated to the pediatric population. To date, the efficacy of simple aspiration in children has not been proven in a dedicated pediatric population study.
The objective of this multi-center, prospective pilot study, therefore, is to examine the rate of successful primary spontaneous pneumothorax (PSP) resolution using a simple aspiration technique. Patients diagnosed with PSP at eleven participating MWPSC children’s hospitals will be enrolled and offered a choice of management with either the simple aspiration protocol or management according to their surgeon’s preferences. Prospective data collection will occur for both groups. A subject in the simple aspiration group will undergo the aspiration procedure followed by chest X-ray confirmation of lung expansion. The subject will be observed for a minimum period of 6 hours after the procedure, then a second chest X-ray obtained to rule out recurrence of the pneumothorax. If there is no recurrence, the subject may be discharged to home. If the aspiration procedure is deemed a failure at any point, the subject will be managed according to the surgeon’s preferences.
1. Baumann MH, Strange C, Heffner JE, et al: Management of spontaneous pneumothorax: an American College of Chest Physicians Delphi consensus statement. Chest 2001; 119:590-602.
2. MacDuff A, Arnold A, Harvey J: Management of spontaneous pneumothorax: British Thoracic Society pleural disease guideline 2010. Thorax 2010; 65(Suppl 2):ii18-ii31.
3. Noppen M, Alexander P, Driesen P, et al: Manual aspiration versus chest tube drainage in first episodes of primary spontaneous pneumothorax. Am J Respir Crit Care Med 2002; 165:1240-1244.
4. Robinson PD, Cooper P, Ranganathan SC. Evidence-based management of paediatric primary spontaneous pneumothorax. Paediatr Respir Rev 2009; 10:110-117.
Nonoperative Management of Uncomplicated Appendicitis
This study will examine the short term outcomes of various methods of abdominal wall closure for babies with gastroschisis using inpatient data. By ascertaining the outcomes of each technique, we will be able to improve patient care by determining the safer and more efficacious method of closure. The following are the primary aims for this study:
Aim 1: To provide a descriptive study of gastroschisis closure and subsequent feeding regimen among the centers of the MWPSC.
Aim 2: To compare the complications of sutureless versus sutured closure.
Aim 3: To compare the incidence, treatment methods, and outcomes of patients with complicated gastroschisis.
Aim 4: Use these data to develop a prospective protocol to improve care across all centers.
Evaluating and Improving the Surgical Management of Ovarian Lesions in Girls
Traditionally, children presenting with appendicitis are referred for urgent appendectomy. Recent improvements in both the quality and availability of diagnostic imaging now allow for better pre-operative characterization of appendicitis including the 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.
Several recent European randomized controlled trials demonstrated that therapy with antibiotics alone is an effective treatment option for adults with appendicitis with no increase in the rate of complicated appendicitis. An ongoing study from Nationwide Children’s Hospital in Columbus, Ohio, is demonstrating the effectiveness of a non-operative treatment strategy in children with suspected uncomplicated appendicitis. At interim analysis with a median follow-up of 7 months, non-operative management has an 81% success rate with no increase in the rate of complicated appendicitis (non-operative management group 3% vs. surgery group 13%).
The objective of this study is to perform a multi-institutional study to examine the consistency of the treatment outcomes of a non-operative treatment strategy across the MWPSC. Patients diagnosed with uncomplicated appendicitis without a fecalith at participating institutions between April 2015 and April 2018 will be offered a choice of non-operative management or appendectomy. Outcomes will include determining the consistency of the success rate of non-operative management and comparing differences in complication rates, cost of care, and quality of life between patients choosing non-operative management and those choosing appendectomy.
Patients diagnosed with uncomplicated appendicitis without a fecalith between April 2015 and April 2017 will choose between non-operative management and appendectomy. Data to be collected include patient demographics, clinical information related to the diagnosis and hospital admission along with patient-centered quality of life measures. Long-term follow-up will be conducted by phone to collect information on post-treatment morbidity, including disability days, and healthcare satisfaction. All data will be collected in a central Research Electronic Data Capture (REDCap) database.
Development of a Predictive Index for Fecal Continence in Children with Anorectal Malformations
The majority of ovarian lesions in girls are benign in nature. Options for the surgical management include oophorectomy and ovary-sparing surgery (OSS). We conducted a multi-institutional retrospective review in order to characterize the surgical management of ovarian lesions in girls. The review included patients with a surgically-managed ovarian lesion, including ovarian cysts, torsions, and neoplasms, who were managed between 2010 and 2016 at one of the MWPSC institutions and resulted in an algorithm to aid surgeons in determining under what circumstances ovarian sparing is appropriate with the intent of increasing ovarian salvage.
We are now embarking on a prospective study to determine the validity of this algorithm and its effects on the rate of ovarian salvage for benign ovarian masses in girls. This study is supported by a $394,000 grant from the Thrasher Research Fund.
Retrospective Multi-institutional Study Examining Current Management of Breast Masses in Female Pediatric and Adolescent Patients
This is a prospective observational study in which surgeons will examine the inguinal canal during laparoscopy for pyloromyotomy and define the absence or presence of a patent processus vaginalis (PPV). The presence of scrotal sac/labial air will be assessed as well as the estimated depth of the PPV.
We estimate that we will recruit 1000 patients through the MWPSC in the next two years which will allow us to estimate the likelihood of developing a symptomatic hernia by age 5. We will follow this cohort for 20 years.
Children with anorectal malformations (ARM) can suffer from impaired functional outcomes related to fecal continence. Parents of children with ARM appropriately ask questions related to the potential for future fecal continence in their children. Our current knowledge of the long term outcomes of children in this population is limited and often based upon personal experience and professional judgment.
The type of anorectal malformation, the sacral ratio and associated sacral anomalies, and spinal abnormalities, have each been implicated as factors associated with functional outcomes, but the extent to which these factors interact with each other and affect fecal incontinence has not previously been determined. Currently, there is no available validated quantitative tool for assisting surgeons and gastroenterologists in counseling parents and benchmarking their outcomes.
This study evaluates fecal continence in pediatric patients previously treated for ARM. It is a multi-institutional cohort study that will retrospectively identify patients who have had a primary repair of their ARM, have undergone sacral and spinal imaging, and are available to complete a prospective survey on continence. Each variable of interest will be evaluated in univariable logistic regression and then multivariable regression to identify independent predictors of fecal continence. A forward selection model with 5-fold cross-validation will be used to identify the optimal model with the lowest misclassification rate and the highest area under the receiver operating characteristic curve.
Natural History of Patent Processus Vaginalis in Infants
The primary objective of this project is to understand:
(1) Current practices with regard to postoperative opioid prescribing and education by providers
(2) Opioid use after common procedures with the goal of creating evidence-based guidelines for prescribing to limit excess but maintain adequate pain control
(3) Storage and disposal patterns of opioids in the home
Congenital lung malformations are rare birth defects with a variable natural history. However, because of their propensity to cause breathing problems, lung infections, cancer, and other complications, surgical removal continues to be the standard treatment of these lesions at most centers. Increasingly, surgeons are operating on asymptomatic patients at young ages (due to the increased detection of these lesions in utero), but the operative morbidity of the surgery itself has not been well analyzed in a large group of patients.
This is a retrospective review of the outcomes of all pediatric patients with congenital lung malformations managed at one of the eleven children's hospital members of the MWPSC. The goal of the study is to better understand the outcomes of surgical treatment and to identify areas where patient care could be improved and optimized.
Breast masses in female children and adolescents are commonly managed by pediatric surgeons. There is, however, a paucity of research in this area. In contrast to the management of breast masses in adults, there is currently a wide variation in the treatment protocols for pediatric breast masses. We are conducting a multi-institutional retrospective review to characterize the preoperative management, radiologic and pathologic findings and outcomes of female pediatric and adolescent patients with breast masses across the 11 children’s hospitals in the United States in the MWPSC.
This is a multicenter, prospective, observational cohort study investigating outcomes of current pilonidal disease management strategies across Children’s Hospitals in the Midwest Pediatric Surgical Consortium.
Our research is not expected to have an impact in clinical decision-making as the data collected will be parallel to current standard management as per the clinicians’ practices; however, the recommendations for medical management and the technique for the Gips procedure will be grossly standardized per group consensus.
This is a prospective observational cohort study rather than a randomized controlled trial due to the wide variety of management strategies and surgical techniques, high variation in reported outcomes, lack of high-quality evidence to determine a particular standard of care, and variable surgeon experience with novel techniques.
Outcomes of Sutured and Sutureless Gastroschisis Closure: A Multi-Institutional Retrospective Review
Midwest Pediatric Surgery Consortium
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