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

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.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.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).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.