Objective: The aim was to compare recurrence of gastroesophageal reflux disease (GERD) in children randomized to laparoscopic (LF) or open Nissen fundoplication (OF).
Background: LF is considered superior to OF by most pediatric surgeons even though this has not been shown in any randomized controlled trial in children.
Methods: 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.
Results: 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).
Conclusions: Children operated with LF have a higher recurrence rate of GERD than those operated with OF.