Is delayed surgery really better for congenital diaphragmatic hernia?: A prospective randomized clinical trial

doi:10.1016/S0022-3468(96)90176-1

Journal of Pediatric Surgery

Volume 31, Issue 11, November 1996, Pages 1554-1556

https://doi.org/10.1016/S0022-3468(96)90176-1 Get rights and content

Abstract

Delayed surgery has become widely accepted in the management of congenital diaphragmatic hernia after comparing outcomes only with historical retrospective controls. It was the aim of this study to compare early and delayed hernia repair in a randomized prospective clinical trial. Fiftyfour infants were randomized to receive either early repair (within 4 hours of admission) or delayed repair (more than 24 hours after birth). The survival rate was higher for the delayed group (57% v 46%), but the difference was not significant (difference: −11; 95% confidence limits: −37.5, 15.5). There were no significant differences between the two groups with respect to length of hospital stay, ventilator dependency, or survival time. Recorded preoperative risk factors were similar for the two groups. Eight infants in the delayed repair group died without having undergone surgery. The optimum time for surgery still needs clarification.

References (10)

JC Langer et al.
Timing of surgery for congenital diaphragmatic hernia: Is emergency operation necessary?
J Pediatr Surg
(1988)
FWJ Hazebroek et al.
Congenital diaphragmatic hernia: impact of preoperative stabilization. A prospective pilot study in 13 patients
J Pediatr Surg
(1988)
M Nio et al.
A prospective randomized trial of delayed versus immediate repair of congenital diaphragmatic hernia
J Pediatr Surg
(1994)
CJH Stolar et al.
Extracorporeal membrane oxygenation and neonatal respiratory failure: Experience from the Extracorporeal Life Support Organization
J Pediatr Surg
(1991)
MR Harrison et al.
Correction of congenital diaphragmatic hernia in utero, V. Initial clinical experience
J Pediatr Surg
(1990)

There are more references available in the full text version of this article.

Cited by (59)

Surgical Management of Congenital Diaphragmatic Hernia
2022, Clinics in Perinatology
Operative repair in congenital diaphragmatic hernia: How long do we really need to wait?
2022, Journal of Pediatric Surgery
Citation Excerpt :
Early repair was defined as up to 4–6 h age, whereas late repair was greater than 24 or 96 h of life, respectively. Relative to current data from the CDH Registry, ECMO rates in the Nio et al. study were very high in both study arms, 67% (early) and 89% (late), while survival rates were quite low in both groups of the trial by de la Hunt, 46% (early) and 57% (late) [9,10]. Subsequently, recommendations have been made by several study groups to repair the defect when “physiologic stability has been achieved” [12–14].
To analyze preoperative cardiopulmonary support and define preoperative stability relative to timing of surgical repair for CDH neonates not on ECMO.
We retrospectively analyzed repeated measures of oxygenation index (OI; Paw*FiO₂×100/PaO₂) among 158 neonates for temporal preoperative trends. We defined physiologic stability using OI and characterized ventilator days and discharge age relative to delay in repair beyond physiologic stability.
The OI in the first 24 h of life was temporally reliable and representative of the preoperative mean (ICC 0.70, 95% CI 0.61–0.77). A pre-operative OI of ≤ 9.4 (AUC 0.95) was predictive of survival. Surgical delay after an OI ≤ 9.4 resulted in increased ventilator days (1.4, 95% CI 1.1–1.9) and discharge age (1.5, 95% CI 1.2–2.0). When prospectively applied to a subsequent cohort, an OI ≤ 9.4 was again reflective of physiologic stability prior to repair.
OI values are temporally reliable and change minimally after 24 h age. Delay in surgical repair of CDH beyond initial stability increases ventilator days and discharge age without a survival benefit.
Prognosis study, Level III.
Impact of Objective Echocardiographic Criteria for Timing of Congenital Diaphragmatic Hernia Repair
2018, Journal of Pediatrics
To assess the impact of specific echocardiographic criteria for timing of congenital diaphragmatic hernia repair on the incidence of acute postoperative clinical decompensation from pulmonary hypertensive crisis and/or acute respiratory decompensation, with secondary outcomes including survival to discharge, duration of ventilator support, and length of hospitalization.
The multidisciplinary congenital diaphragmatic hernia management team instituted a protocol in 2012 requiring the specific criterion of echocardiogram-estimated pulmonary artery pressure ≤80% systemic blood pressure before repairing congenital diaphragmatic hernias. A retrospective review of 77 neonatal patients with Bochdalek hernias repaired between 2008 and 2015 were reviewed: group 1 included patients repaired before protocol implementation (n = 25) and group 2 included patients repaired after implementation (n = 52).
The groups had similar baseline characteristics. Postoperative decompensation occurred less often in group 2 compared with group 1 (17% vs 48%, P = .01). Adjusted analysis accounting for repair type, liver herniation, and prematurity yielded similar results (15% vs 37%, P = .04). Group 2 displayed a trend toward improved survival to 30 days postoperatively, though this did not reach statistical significance (94% vs 80%, P = .06). Patient survival to discharge, duration of ventilator support, and length of hospitalization were not different between groups.
The implementation of a protocol requiring echocardiogram-estimated pulmonary arterial pressure ≤80% of systemic pressure before congenital diaphragmatic hernia repair may reduce the incidence of acute postoperative decompensation, although there was no difference in longer-term secondary outcomes, including survival to discharge.
Management of congenital diaphragmatic hernia: A systematic review from the APSA outcomes and evidence based practice committee
2015, Journal of Pediatric Surgery
Citation Excerpt :
Based on these results, they concluded that there was no advantage to early or late repair and advocated for individualization of care based on clinical course, with the stable ones repaired early and the others later when stabilized. De la Hunt et al. [86] performed a similar trial in the UK over the same time period. Their goal was to randomize 60 cases over 4 years, but they stopped at 54 patients due to accrual issues.
Variable management practices complicate the identification of optimal strategies for infants with congenital diaphragmatic hernia (CDH). This review critically appraises the available evidence to provide recommendations.
Six questions regarding CDH management were generated. English language articles published between 1980 and 2014 were compiled after searching Medline, Cochrane, Embase and Web of Science. Given the paucity of literature on the subject, all studies irrespective of their rank in the levels of evidence hierarchy were included.
Gentle ventilation with permissive hypercapnia provides the best outcomes. Initial high frequency ventilation may be considered but its overall efficacy is unproven. Routine inhaled nitric oxide (iNO) or other medical adjuncts for acute, severe pulmonary hypertension demonstrate no benefit. Evidence does not support routine administration of pre- or postnatal glucocorticoids. Mode of extracorporeal membrane oxygenation (ECMO) has little bearing on outcomes. While the overall timing of repair does not impact outcomes, early repair on ECMO has benefits. Open repair leads to significantly fewer recurrences. Polytetrafluoroethylene (PTFE) is the most durable patch repair material.
Limited high-level evidence prevents the development of robust management guidelines for CDH. Prospective, multi-institutional studies are needed to identify best practices and optimize outcomes.
Controversies in the management of severe congenital diaphragmatic hernia
2014, Seminars in Fetal and Neonatal Medicine
Citation Excerpt :
Although it seems reasonable to delay surgical intervention to improve the physiologic derangements and to reduce the risks of iatrogenic injuries leading to rapid, potentially irreversible, deterioration of the clinical status, scientific evidence is lacking. There are two prospective randomized clinical trials comparing early versus delayed CDH repair and one systematic Cochrane review that have failed to show a difference in mortality and neonatal morbidity [109–111]. These studies were conducted in the late 1990s.
Despite years of progress in perinatal care, severe congenital diaphragmatic hernia (CDH) remains a clinical challenge. Controversies include almost every facet of clinical care: the definition of severe CDH by prenatal and postnatal criteria, fetal surgical intervention, ventilator management, pulmonary hypertension management, use of extracorporeal membrane oxygenation, surgical considerations, and long-term follow-up. Breakthroughs are likely only possible by sharing of experience, collaboration between institutions and innovative therapies within well-designed multicenter clinical trials.
A risk-stratified analysis of delayed congenital diaphragmatic hernia repair: Does timing of operation matter?
2014, Surgery (United States)
Citation Excerpt :
However, the exact definition or criteria for timing of operation remains unknown. Although several reports have advocated for a delayed strategy of hemodynamic stability before operative repair, the definition of physiologic stability can be variable.5,17-21 Some centers have defined stability and indications for repair in high-risk patients who require operative repair on ECMO16; however, few data exist outlining timing of repair in lower risk infants with CDH.
Congenital diaphragmatic hernia (CDH) remains a significant cause of death in newborns and, despite improved outcomes with multimodality therapies, optimal timing of repair remains undefined. We sought to evaluate the influence of surgical timing on patient outcomes and hypothesized that delayed repair does not improve survival in CDH.
Prospectively collected data from 1,385 CDH Registry infants without preoperative extracorporeal membrane oxygen therapy (ECMO) were evaluated. Patients were stratified by timing of repair: Day of life (DOL) 0–3 (group 1), 4–7 (group 2), or >8 (group 3), and the effect of surgical timing on mortality was determined by logistic regression and risk-adjusted for severity of illness.
The unadjusted odds ratio (OR) for mortality increased significantly with delayed repair (group 2, 1.73 [95% CI, 1.00–2.98; group 3, 3.42 [95% CI, 1.97–5.96]). However, when adjusted for severity of illness, delay in repair did not predict increased mortality (group 2, 1.2 [95% CI, 0.7–2.2]; group 3, 1.4 [95% CI, 0.8–2.6]), nor did it portend an increased need for postoperative ECMO (group 2, 1.1 [95% CI, 0.5–2.4]; group 3, 0.5 [95% CI, 0.2–1.4]).
After adjustment for known risk factors, the timing of CDH repair in low-risk infants does not seem to influence mortality. However, specific clinical parameters guiding timing of elective CDH repair remain unknown.

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Is delayed surgery really better for congenital diaphragmatic hernia?: A prospective randomized clinical trial

Abstract

J Pediatr Surg

J Pediatr Surg

J Pediatr Surg

J Pediatr Surg

J Pediatr Surg