Professor of Pediatric Surgery and Pediatrics
E-mail: martin.blakely@vumc.org
Phone: (615) 936-1050
Hernia Repair Clinical Trial
Lab Members
Research Fellow Eileen Duggan, MD (in MPH program)
Statistician Leena Choi, PhD
Pediatric Surgery Clinical Research Program
The vast majority of pediatric surgical treatments are not based on evidence supporting their effectiveness. Randomized clinical trials, or even well designed prospective observational studies, are fairly rare within pediatric surgery. Because high quality clinical research studies are rare within our field, there is often much variability in how individual surgeons treat many conditions and the comparative outcomes with various treatments is usually not known. The costs associated with these treatments are likewise usually unknown.
Our primary focus is to conduct prospective clinical studies evaluating surgical treatments for common conditions. Because many pediatric surgical conditions are relatively uncommon (or rare), these studies typically involve multiple centers across the United States. We are working with many other surgical groups within a group known as the Pediatric Surgery Clinical Research Collaborative (PedSRC) to facilitate the conduct of these studies. We are also actively working with the American Pediatric Surgery Association (APSA) Clinical Trials and Outcomes Committee. Active areas of interest currently include: surgical treatment of necrotizing enterocolitis or spontaneous intestinal perforation in premature infants; timing of inguinal hernia repair in premature infants (i.e. prior to NICU discharge versus later); comparative outcomes of laparoscopic and open pyloromyotomy; and surgical treatment options for perforated appendicitis (early or interval appendectomy).
We are also involved in developing clinical practice guidelines (CPG) for common surgical conditions. Along with specific research studies, it is important to implement evidence when available into treatment guidelines to reduce variability of care and allow outcomes to be accurately measured with the goal of improving care.
Ongoing Studies
- A Randomized Clinical Trial Comparing Safety And Neurodevelopmental Outcomes Of Inguinal Hernia Repair Prior To NICU Discharge Versus After 55 Weeks Post Conceptual Age In Premature Neonates. (Clinicaltrials.gov NCT 01678638)
- Necrotizing Enterocolitis Surgery Trial. (Clinicaltrials.gov NCT 01029353)
- Comparison of Adverse Event Rate and Hospital Costs of Laparoscopic and Open Pyloromyotomy in Infants with Hypertrophic Pyloric Stenosis.
- Determination of Surgeon Preferences Related to Laparoscopic and Open Pyloromyotomy.
- Evaluation Of A Clinical Pathway To Reduce CT Utilization In Children With Blunt Abdominal Trauma.
- Determination Of Variability In Surgical Treatment Approach And Outcomes For Children With Perforated Appendicitis: Evaluation Of The PHIS Database.
- Determination Of Surgical Treatment Patterns And Outcomes For Premature Infants With Inguinal Hernia:
- Evaluation Of The Pediatrix Database.
- Evaluation of Non Routine Events in Surgical Neonates.
- Evaluation of the Reliability of the Pediatric National Surgical Quality Improvement Program.
Selected Publications
Huang EY, Tolley EA, Blakely ML, Langham MR. Changes in hospital utilization and management of Hirschsprungs disease: analysis using the KIDS inpatient database. Ann Surg 2013:257:371-5.
Myers A, Williams R, Giles K, Waters T, Eubanks J, Hixson SD, Huang E, Langham M and M Blakely. Hospital Cost Analysis of a Prospective, Randomized Trial of Early versus Interval Appendectomy for Perforated Appendicitis in Children. J Am Coll Surg, 2012:214:427-35.
Downard CD, Renaud E, St. Peter SD, Abdullah F, Islam S, Aspelund G, and M Blakely. Treatment of Necrotizing Enterocolitis: An American Pediatric Surgical Association Outcomes and Clinical trials Committee Systematic Review. J Pediatr Surg, 2012:47:2111-2122.
St Peter SD, Calkins CM, Goldin AB, Chen C, Downard CD, Huang EY, Cassidy L, Saito J, Arca MJ, Abdullah F, Islam S and M Blakely. The Diagnosis and Management of Empyema In Children: A Systematic Review from The APSA Outcomes and Clinical Trials Committee. J Pediatr Surg, 2012:47:2101-10.
Blakely ML, Williams R, Dassinger MS, Eubanks JW 3rd, Fischer P, Huang EY, Paton E, Culbreath B, Hester A, Streck C, Hixson SD, Langham MR Jr. Early vs interval appendectomy for children with perforated appendicitis. Arch Surg 2011:146:660-5.
Williams RF, Blakely ML, Fischer PE, Streck CJ, Dassinger MS, Renaud E, Eubanks JW, Huang E, Hixson SD, and MR Langham. Diagnosing Ruptured from Acute Appendicitis in Children Preoperatively. J Am Coll Surg 2009; 208(5):819-25; discussion 826-8.
Kao LS, Tyson JE, Blakely ML, and KP Lally. Clinical Research Methodology I: Introduction to Randomized Trials. J Am Coll Surg 206:361-369, 2008.
Moss RL, Dimmitt RA, Barnhart DC, Sylvester KG, Brown RL, Powell DM, Islam S, Langer JC, Sato TT, Brandt ML, Lee H, Blakely ML, Lazar EL, Hirschl RB, Kenney BD, Hackam DJ, Zelterman D, Silverman BL. Laparotomy versus peritoneal drainage for necrotizing enterocolitis and perforation. N Engl J Med. 2006 May 25;354(21):2225-34.
Blakely ML, Tyson JE, Lally KP, McDonald S, Stoll BJ, Stevenson DK, Poole WK, Jobe AH, Wright LL, Higgins RD, Neonatal Research Network. Laparotomy vs. Peritoneal Drainage for Necrotizing Enterocolitis or Isolated Intestinal Perforation in Extremely Low Birth Weight Infants; Outcomes through 18 Months Adjusted Age. Pediatrics. 2006 Apr;117(4):e608-7.
Blakely ML, Lally KP, McDonald S, Brown RL, Barnhart DC, Ricketts RR, Thompson WR, Scherer, LR, Klein MD, Letton RW, Chwals WJ, Touloukian RJ, Kurchubasche AG, Skinner MA, Moss RL, Hilfiker ML, NEC Subcommittee of the NICHD Neonatal Research Network. Post Operative Outcomes of Extremely Low Birth-Weight Infants With Necrotizing Enterocolitis or Isolated Intestinal Perforation: A Prospective Cohort Study by the NICHD Neonatal Research Network. Ann Surg. 2005 Jun;241(6):984-9.