Randomized Controlled Trial of Laparoscopic and Open Nissen Fundoplication in Children.

Abstract

The aim was to compare recurrence of gastroesophageal reflux disease (GERD) in children randomized to laparoscopic (LF) or open Nissen fundoplication (OF). LF is considered superior to OF by most pediatric surgeons even though this has not been shown in any randomized controlled trial in children. Patients referred for fundoplication between 2003 and 2009 were eligible for inclusion in this 2-center, unstratified, randomized, parallel-group study conducted in Norway. The main outcome measure was recurrence of GERD, which was defined as GERD combined with a reflux index greater than 4 on pH monitoring and/or gastroesophageal reflux and/or herniated wrap on upper gastrointestinal (UGI) contrast study. Only experienced laparoscopic surgeons performed the LF. Postoperative follow-up included 24-hour pH monitoring, UGI contrast study, and a clinical examination at 6 months and phone interviews after 1, 2, and 4 years. Eighty-seven children were included and randomized to either LF (n = 44) or OF (n = 43). Median age was 4.7 years (0.2-15.4) in the LF group and 3.7 years (0.2-14.2) in the OF group. Twenty-three patients in both groups were neurologically impaired. Median follow-up time was 4.0 years (0.3-8.9). Significantly more patients undergoing LF (37%) experienced recurrence of GERD compared to those undergoing OF (7%); risk ratio for recurrence in the LF group was 5.2 (95% confidence interval: 1.6-16.6) (P = 0.001). Children operated with LF have a higher recurrence rate of GERD than those operated with OF.