Original article
Preventive antireflux surgery in neonates with congenital diaphragmatic hernia: a single-blinded prospective study

https://doi.org/10.1016/j.jpedsurg.2011.03.085Get rights and content

Abstract

Objective

Congenital diaphragmatic hernia (CDH) is known to be a predisposing factor in gastroesophageal reflux (GER) leading to pulmonary and nutritional problems. The aim of this prospective, randomized, patient-blinded study was to evaluate the benefit of antireflux surgery at the time of CDH repair.

Methods

From 2003 to 2009, 79 neonates with left-sided CDH were included. Forty-three had regular hernia closure. Thirty-six patients additionally had fundoplication at hernia repair. Follow-up was at 6, 12, and 24 months after birth with a standardized questionnaire and a thorax radiograph. Patients with clinical signs for GER were evaluated with upper gastrointestinal series and 24-hour pH-metry.

Results

Seventy-nine of 263 patients participated in this prospective trial. Survival rate was 88.61%. The GER symptoms were almost significantly more frequent in the group without concomitant fundoplication at the age of 6 months. At 24 months, the difference between both groups was not significant anymore. Development of body weight in the first 2 years of life was similar in both groups. No complications related to initial antireflux surgery were noted.

Conclusion

Patients profit from fundoplication at CDH repair only within the first year of life. At the present point of this study, simultaneous fundoplication at the time of primary CDH repair cannot be recommended as a standard procedure in all patients with left-sided CDH.

Section snippets

Background

The incidence of gastroesophageal reflux (GER) in infants with congenital diaphragmatic hernia (CDH) is from 28% to 69% [1], [2], [3], [4], [5], [6], [7], and a surgical antireflux procedure is required in 8% to 21% of all CDH patients. Different anatomical predictors for GER have been described, such as herniation of the liver or the stomach, defect size, patch repair, and the use of extracorporal membrane oxygenation (ECMO). Because of the high incidence of GER in CDH, fundoplication

Patients and methods

From 2003 to 2009, 79 patients were included in a single-blinded prospective study. Inclusion criteria were left-sided diaphragmatic hernia and hernia repair by open surgery. The included patients were randomly assigned to 2 groups: group wARS with hemifundoplication at the time of CDH repair and group N with regular CDH repair. Thirty-six patients were assigned to group wARS, whereas 43 neonates served as controls (group N). There was allocation concealment. Written consent of the parents was

Results

From 12/08/2003 to 05/22/2009, 263 neonates with CDH were treated in our institution. Seventy-nine patients with left-sided hernia were included in our study (36 females and 43 males). One hundred eighty-four patients had to be excluded from this trial, including 57 with right-sided diaphragmatic hernia; 3 patients with left-sided hernia and thoracoscopic closure; 2 with bilateral hernias; 118 with left-sided hernias whose parents did not give consent to participate in the study; and, finally,

Discussion

Congenital diaphragmatic hernia is a complex disorder and cannot be reduced to the mechanical problem of diaphragmatic gap.

Patients with CDH often show a failure to thrive. Reasons for that are impairment by operations and ECMO including a long stay in the intensive care unit during the perinatal period and lung hypoplasia. Later on, persistent respiratory effort and feeding problems delay weight gain. Poor pulmonary status and failure to thrive in CDH patients [5], [7] can be worsened by the

Conclusion

In this patient-blinded prospective study, the significance of antireflux surgery in CDH was evaluated. An almost significant trend for a lower incidence of GER symptoms was found at the age of 6 months, but the benefit of preventive hemifundoplication decreases within the first 2 years of life. No difference in the thriving curve of patients compared with the control group was found at any time. Therefore, pending the findings of long-term results, currently, preventive antireflux surgery

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    Two retrospective studies on a small number of patients have shown potential beneficial effects of preventive fundoplication, mainly on growth [9,19]. However, the only prospective randomized controlled study showed no difference in GERD occurrence or growth with a follow-up of 2 years after preventive hemi-fundoplication in left-CDH [27]. The authors concluded that a concomitant fundoplication at the time of CDH repair could not be recommended as a standard procedure with left-sided CDH.

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    The high prevalence of gastroesophageal reflux and the severity of its sequelae, and the large proportion of patients with CDH requiring antireflux procedures (as many as more than 60% of infants operated on for CDH)24,52 led some authors to propose preventive fundoplication at the time of CDH repair,28,49 with controversial results. Some authors found significant benefit of antireflux procedure performed at the time of CDH repair,57–59 while in the single randomized controlled trial on the issue, Maier et al.46 found no long-term profit from fundoplication at CDH repair. FTT is frequent in CDH survivors, with a prevalence ranging from 14% to 63%.60,61

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This clinical trial has been registered at the Medical Ethics Commission II, Universitätsklinikum Mannheim, University of Heidelberg, and was approved 09/02/2003.

1

Susanne Maier and Katrin Zahn equally contributed to this paper.

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