Nissen fundoplication in children with and without neurological impairment: A prospective cohort study.

BACKGROUND: It is assumed that children with neurological impairment (NI) have inferior results after fundoplication compared to those without NI (non-NI). The aim of this study was to assess outcome after fundoplication in children with and without NI. METHODS: 87/105 patients (46 NI, 41 non-NI) undergoing fundoplication between 2003 and 2009 were included in this prospective two-center cohort study. Complications occurring within the first 30days were scored from 0 to 100 by the comprehensive complication index (CCI). Follow-up included clinical examination, upper gastrointestinal contrast study and 24-h pH monitoring 6months postoperatively, then phone-interviews 1, 2 and 4years later. RESULTS: There were no statistical differences in age (NI 3.1 years [0.2-15.2] vs non-NI 5.0 years [0.4-15], p=.14) or in total CCI score (NI 20.9 [0-44.9] vs non-NI 8.7 [0-40.6], p=.57). Hospital stay was longer for NI children (9days [4-57] vs non-NI: 4days [2-16], p<0.001). More than 90% of parents in both groups reported that the fundoplication had improved the child's overall condition. Recurrence of gastroesophageal reflux disease (GERD) was diagnosed in 12 NI and 7 non-NI patients (p=.31). CONCLUSIONS: Early complications, GERD recurrence, and long-term parental satisfaction after fundoplication did not differ between NI and non-NI patients.

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

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.