EBNEO COMMENTARY: THE IMPACT OF TIMING OF INGUINAL HERNIA REPAIR ON OUTCOMES IN PRETERM INFANTS

[EBNEO]

 

Puneet Sharma and Brian King from US review EbNeo March 2024 Article of the Month: HIP Trial Investigators; Blakely ML, Krzyzaniak A, Dassinger MS, Pedroza C, Weitkamp J, Gosain A, et al. Effect of Early vs Late Inguinal Hernia Repair on Serious Adverse Event Rates in Preterm Infants: A Randomized Clinical Trial. JAMA 2024;331(12):1035-44. PMID 38530261.

READ HERE!

Acta Commentary:

Acta Paediatrica - 2024 - Sharma - EBNEO Commentary The impact of timing of inguinal hernia repair on outcomes in preterm.pdf

Optimal timing of inguinal hernia repair is uncertain due to the competing concerns around risk of anesthesia in neonates and risk of hernia-related complications such as incarceration (1). This study is a well-designed, multicentered trial that demonstrates short term benefits to performing inguinal hernia repair after NICU discharge.  Furthermore, the use of Bayesian analyses allows for more pragmatic and clinically oriented interpretation of the outcomes.

 Late repair led to fewer serious adverse events and fewer days in the hospital, with a greater effect in vulnerable populations like extremely preterm infants and those with BPD.  Of note, there were more laparoscopic procedures in the early repair group, which are associated with shorter operation time and less complications than laparotomy (2).  However, the combination of better outcomes for patients and potentially less healthcare utilization (and costs), makes late repair an appealing choice. Furthermore, this intervention is very straightforward to implement.

 However, the broad definition of serious adverse event that is used in the composite primary outcome highlights important limitations when interpreting the results. For example, the most common adverse event in both groups was apnea requiring intervention, which could have a very broad range of clinical significance.  Furthermore, cardiac arrest, of which there were three in the late repair group compared to zero in the early, is weighted equally to apnea. Similarly, more infants in the late repair group had incarcerated hernia, but this was broadly classified and included both surgical repairs and bedside reductions.

 A major limitation with composite outcomes is that they can provide a false equivalency between included outcomes, making it difficult to assess an intervention’s effect on individual outcomes. This limitation is well documented, and yet many trials in neonatology continue to use them due to their benefits when powering trials (3).  Alternate statistical approaches exist to address some of these limitations, one of which is the desirability of outcome ranking (DOOR). DOOR uses a patient-centric approach to rank outcomes from most to least desirable and was recently used in a post-hoc analysis of a neonatal trial (4).  Interpretation of this study’s findings might change using the DOOR approach. For example, more patients in the late repair group did not undergo surgery, often due to spontaneous closure. This outcome was not emphasized by the authors but may be a desirable outcome ranked highly by families.  Similarly, the outcomes of apnea and incarceration would likely not be ranked equivalently using the DOOR approach.

 Another important factor to consider with late repair is the additional burden it can place on families. Families that were deemed unable to follow up were excluded, but this is an important cohort.  Families may prefer repair during admission as both a financial decision and convenience.  While the late repair group had fewer hospital days, a readmission was required. Greater financial burden may be placed on families with readmission, both due to increased cost-sharing and out-of-pocket costs (5). If many of the adverse events in the early repair group are short term and mild, some families may still elect for early repair depending on their values and preferences.  Differences in long term outcomes, which are being studied, may also alter the potential tradeoffs.  Studies have been conducted to clarify what outcomes are most important to parents of children with bronchopulmonary dysplasia (6).  A similar study in this patient population would undoubtedly provide important context on the timing of repair.

REFERENCES

Wang KS; Committee on Fetus and Newborn, American Academy of Pediatrics; Section on Surgery, American Academy of Pediatrics. Assessment and management of inguinal hernia in infants. Pediatrics. 2012;130(4):768-773. PMID: 23008462.

Davies DA, Rideout DA, Clarke SA. The International Pediatric Endosurgery Group Evidence-Based Guideline on Minimal Access Approaches to the Operative Management of Inguinal Hernia in Children. J Laparoendosc Adv Surg Tech A. 2020;30(2):221-227. PMID: 28140751.

Cordoba G, Schwartz L, Woloshin S, Bae H, Gøtzsche PC. Definition, reporting, and interpretation of composite outcomes in clinical trials: systematic review. BMJ. 2010;341:c3920. PMID: 20719825.

Katheria AC, El Ghormli L, Rice MM, Dorner RA, Grobman WA, Evans SR. Application of desirability of outcome ranking to the milking in non-vigorous infants trial. Early Hum Dev. 2024;189:105928. PMID: 38211436.

King BC, Mowitz ME, Zupancic JAF. The financial burden on families of infants requiring neonatal intensive care. Semin Perinatol. 2021;45(3):151394. PMID: 33581862.

Callahan KP, Kielt MJ, Feudtner C et al. Ranking future outcomes most important to parents of children with bronchopulmonary dysplasia. J Pediatr. 2023;259:113455. PMID: 37172804.

Acta Paediatrica - 2024 - Sharma - EBNEO Commentary The impact of timing of inguinal hernia repair on outcomes in preterm.pdf

[Stefan Johansson]

Thanks for sharing, this is an interesting paper!

What we do in Stockholm - hernias are typically repaired as the "last thing" before discharge home. This works well in our local experience.