Outcome a decade after laparoscopic and open Nissen fundoplication in children: results from a randomized controlled trial

Thomas J Fyhn, Morten Kvello, Bjørn Edwin, Ole Schistad, Are H Pripp, Ragnhild Emblem, Charlotte K Knatten, Kristin Bjørnland, Thomas J Fyhn, Morten Kvello, Bjørn Edwin, Ole Schistad, Are H Pripp, Ragnhild Emblem, Charlotte K Knatten, Kristin Bjørnland

Abstract

Background: Randomized controlled trials (RCT) comparing long-term outcome after laparoscopic (LF) and open fundoplication (OF) in children are lacking. Here we report recurrence rates and time to recurrence, frequency of re-interventions, use of antisecretory drugs, gastrointestinal symptoms, and patient/parental satisfaction a decade after children were randomized to LF or OF.

Methods: Cross-sectional long-term follow-up study of a two-center RCT that included patients during 2003-2009. Patients/parents were interviewed and medical charts reviewed for any events that might be related to the fundoplication. If suspicion of recurrence, further diagnostics were performed. Informed consent and ethical approval were obtained.

Clinicaltrials: gov: NCT01551134.

Results: Eighty-eight children, 56 (64%) boys, were randomized (LF 44, OF 44) at median 4.4 [interquartile range (IQR) 2.0-8.9] years. 46 (52%) had neurological impairment. Three were lost to follow-up before first scheduled control. Recurrence was significantly more frequent after LF (24/43, 56%) than after OF (13/42, 31%, p = 0.004). Median time to recurrence was 1.0 [IQR 0.3-2.2] and 5.1 [IQR 1.5-9.3] years after LF and OF, respectively. Eight (19%) underwent redo fundoplication after LF and three (7%) after OF (p = 0.094). Seventy patients/parents were interviewed median 11.9 [IQR 9.9-12.8] years postoperatively. Among these, use of anti-secretory drugs was significantly decreased from preoperatively after both LF (94% vs. 35%, p < 0.001) and OF (97% vs. 19%, p < 0.001). Regurgitation/vomiting were observed in 6% after LF and 3% after OF (p = 0.609), and heartburn in 14% after LF and 17% after OF (p = 1.000). Overall opinion of the surgical scars was good in both groups (LF: 95%, OF: 86%, p = 0.610). Patient/parental satisfaction with outcome was high, independent of surgical approach (LF: 81%, OF: 88%, p = 0.500).

Conclusions: The recurrence rate was higher and recurrence occurred earlier after LF than after OF. Patient/parental satisfaction with outcome after both LF and OF was equally high.

Keywords: Child; Fundoplication; Gastroesophageal reflux; Laparoscopy; Randomized.

Conflict of interest statement

Authors Thomas J. Fyhn, Morten Kvello, Bjørn Edwin, Ole Schistad, Are H. Pripp, Ragnhild Emblem, Charlotte K. Knatten, and Kristin Bjørnland have no conflict of interest or financial ties to disclose.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
CONSORT flow chart for long time assessment of GERD recurrence in children randomized to open (OF) and laparoscopic (LF) fundoplication. a CONSORT flow chart for median 4.0 years follow-up. b CONSORT flow chart for median 11.9 years follow-up
Fig. 2
Fig. 2
Kaplan–Meyer plot of gastroesophageal reflux disease (GERD) recurrence in patients randomized to laparoscopic or open fundoplication. The groups were compared using log-rank test. Tick marks indicate censored data
Fig. 3
Fig. 3
Percentage of patients with GER symptoms (heartburn, vomit, and/or regurgitation) before laparoscopic and open fundoplication, and at 1, 2, 4, and 12 years postoperatively. The number of patients/parents able to answer is indicated on the x-axis. Answers from patients with wrap herniation, who used antisecretory drugs and/or had surgical reintervention are also included

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