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