BAPS Paper
A randomized trial of laparoscopic versus open Nissen fundoplication in children under two years of age

https://doi.org/10.1016/j.jpedsurg.2014.11.014Get rights and content

Abstract

Aims

The surgery of gastroesophageal reflux disease (GERD) is common in modern pediatric surgical practice. Any differences in perioperative and long-term clinical outcomes following laparoscopic (LN) or open Nissen (ON) fundoplication have not been comprehensively described in young children. This randomized, prospective study examines outcomes following LN versus ON in children < 2 years of age.

Methods

Four surgeons at a single institution enrolled patients under 2 years of age that required surgical management of GERD, who were then randomized to LN or ON between 2005 and 2012. A universal surgical dressing was employed for blinding. Analgesia and enteral feeding pathways were standardized. The primary outcome was postoperative length of stay. Perioperative outcomes and long-term follow up were collected as secondary outcomes and used to compare groups.

Results

Of 39 enrolled patients, 21 were randomized to ON and 18 to LN. Length of postoperative hospital stay, time of advancement to full enteral feeds, and analgesic requirements were not significantly different between treatment cohorts. The LN group experienced longer median operating times (173 vs 91 min, P < 0.001) and higher surgical charges ($4450 vs $2722, P = 0.002). The incidence of post-discharge complications did not differ significantly between the groups at last follow-up (median 42 months).

Conclusions

This randomized trial comparing postoperative outcomes following LN vs ON did not detect statistically significant differences in short- or long-term clinical outcomes between these approaches. LN was associated with longer surgical time and higher operating room costs. The benefits, risks, and costs of laparoscopy should be carefully considered in clinical pediatric surgical practice.

Section snippets

Study design

This was a single-institution, blinded clinical trial in which patients were randomly assigned to one of two treatment groups in a 1:1 ratio to receive Nissen fundoplication via either laparoscopic or open approach. Parents and nurses were masked to the treatment assignment. The study was approved by the Johns Hopkins Medicine Institutional Review Board (Application 72440) and unmasked data for patient safety and data quality were periodically reviewed by an independent Data and Safety

Results

A total of 39 patients were enrolled and randomized, with 18 (46%) allocated to LN and 21 (54%) to ON (CONSORT Flowsheet Fig. 3). Mean age and weight of the overall patient cohort were 6.4 months and 6.0 kg, respectively. A history of prior surgery or major procedure was present in 14 (36%) of patients, with 5 (13%) having had a prior abdominal surgery or procedure. Comparisons of patient parameters between LN and ON groups (Table 1) showed no significant differences with respect to estimated

Discussion

The scope of this study is of utmost relevance to contemporary pediatric surgical practice. It is widely recognized that infants requiring surgical management of GERD represent a distinct population, with a unique set of technical challenges and a co-morbidity profile that includes high incidence of neurological deficits and congenital abnormalities [9], [10], [11]. However, trends toward increasing use of LN have been largely based on studies outside of this population. Here, we report the

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