Four year follow-up of a randomised controlled trial comparing open and laparoscopic Nissen fundoplication in children

Maurizio Pacilli, Simon Eaton, Merrill McHoney, Edward M Kiely, David P Drake, Joseph I Curry, Keith J Lindley, Agostino Pierro, Maurizio Pacilli, Simon Eaton, Merrill McHoney, Edward M Kiely, David P Drake, Joseph I Curry, Keith J Lindley, Agostino Pierro

Abstract

Objective: To evaluate the 4-year results following a randomised controlled trial (RCT) comparing open (ONF) and laparoscopic (LNF) Nissen fundoplication in children.

Background: It is assumed that long-term results of ONF and LNF are comparable. No randomised studies have been performed in children.

Methods: A follow-up study was performed in children randomised to ONF or LNF (clinicaltrials.gov identifier NCT00259961). Recurrent gastro-oesophageal reflux (GER) was documented by upper gastrointestinal contrast study and/or 24-h pH study. Nutritional status, retching and other symptoms were investigated. A questionnaire was used to assess the quality of life before and after surgery.

Results: Thirty-nine children were randomised to ONF (n=20) or LNF (n=19). There were 15 ONF and 16 LNF neurologically impaired children. One patient (ONF group) was lost to follow-up. Follow-up was 4.1 years (3.1-5.3) for ONF group and 4.1 years (2.6-5.1) for LNF group (p=0.9). Seven neurologically impaired children had died by the time of follow-up (3 ONF, 4 LNF). Incidence of recurrent GER was 12.5% in the ONF and 20% in the LNF (p=ns). One patient in each group underwent redo-Nissen fundoplication. Nutritional status improved in both groups, as indicated by a significant increase in weight Z-score (p<0.01). Gas bloat and dumping syndrome were present in both groups (p=ns). Incidence of retching was lower in the laparoscopic group (p=0.01). Quality of life improved in both groups (p=ns).

Conclusions: Open and laparoscopic Nissen provide similar control of reflux and quality of life at follow-up. LNF is associated with reduced incidence of retching persisting at 4-year follow-up.

Trial registration number: NCT00259961.

Keywords: Gastroenterology; Paediatric Surgery; Procedures.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Figures

Figure 1
Figure 1
Flow diagram showing patients’ recruitment from original study to long-term follow-up.
Figure 2
Figure 2
Weight Z-score in the two groups before and after surgery (follow-up).
Figure 3
Figure 3
Body mass index (BMI) Z-score before and after surgery (follow-up).

References

    1. Capito C, Leclair MD, Piloquet H, et al. Long-term outcome of laparoscopic Nissen-Rossetti fundoplication for neurologically impaired and normal children. Surg Endosc 2008;22:875–80
    1. Kubiak R, Andrews J, Grant HW. Long-term outcome of laparoscopic Nissen fundoplication compared with laparoscopic that fundoplication in children: a prospective, randomized study. Ann Surg 2011;253:44–9
    1. Salminen PT, Hiekkanen HI, Rantala AP, et al. Comparison of long-term outcome of laparoscopic and conventional Nissen fundoplication: a prospective randomized study with an 11-year follow-up. Ann Surg 2007;246:201–6
    1. Kimber C, Kiely EM, Spitz L. The failure rate of surgery for gastro-oesophageal reflux. J Pediatr Surg 1998;33:64–6
    1. McHoney M, Eaton S, Wade A, et al. Inflammatory response in children after laparoscopic vs open Nissen fundoplication: randomized controlled trial. J Pediatr Surg 2005;40:908–13
    1. McHoney M, Wade AM, Eaton S, et al. Clinical outcome of a randomized controlled blinded trial of open versus laparoscopic Nissen fundoplication in infants and children. Ann Surg 2011;254:209–16
    1. McHoney M, Eaton S, Wade A, et al. Effect of laparoscopy and laparotomy on energy and protein metabolism in children: a randomized controlled trial. J Pediatr 2010;157:439–44, 444
    1. Freeman JV, Cole TJ, Chinn S, et al. Cross sectional stature and weight reference curves for the UK, 1990. Arch Dis Child 1995;73:17–24
    1. O'Neill JK, O'Neill PJ, Goth-Owens T, et al. Care-giver evaluation of anti-gastroesophageal reflux procedures in neurologically impaired children: what is the real-life outcome? J Pediatr Surg 1996;31:375–80
    1. Pearl RH, Robie DK, Ein SH, et al. Complications of gastroesophageal antireflux surgery in neurologically impaired versus neurologically normal children. J Pediatr Surg 1990;25:1169–73
    1. Spitz L, Roth K, Kiely EM, et al. Operation for gastro-oesophageal reflux associated with severe mental retardation. Arch Dis Child 1993;68:347–51
    1. Tovar JA, Olivares P, Diaz M, et al. Functional results of laparoscopic fundoplication in children. J Pediatr Gastroenterol Nutr 1998;26:429–31
    1. Bourne MC, Wheeldon C, MacKinlay GA, et al. Laparoscopic Nissen fundoplication in children: 2–5-year follow-up. Pediatr Surg Int 2003;19:537–9
    1. Fonkalsrud EW, Ashcraft KW, Coran AG, et al. Surgical treatment of gastroesophageal reflux in children: a combined hospital study of 7467 patients. Pediatrics 1998;101:419–22
    1. Bais JE, Bartelsman JF, Bonjer HJ, et al. Laparoscopic or conventional Nissen fundoplication for gastro-oesophageal reflux disease: randomised clinical trial. The Netherlands Antireflux Surgery Study Group. Lancet 2000;355:170–4
    1. Draaisma WA, Rijnhart-De Jong HG, Broeders IA, et al. Five-year subjective and objective results of laparoscopic and conventional Nissen fundoplication: a randomized trial. Ann Surg 2006;244:34–41
    1. Ackroyd R, Watson DI, Majeed AW, et al. Randomized clinical trial of laparoscopic versus open fundoplication for gastro-oesophageal reflux disease. Br J Surg 2004;91:975–82
    1. Chrysos E, Tsiaoussis J, Athanasakis E, et al. Laparoscopic vs open approach for Nissen fundoplication. A comparative study. Surg Endosc 2002;16:1679–84
    1. Nilsson G, Larsson S, Johnsson F. Randomized clinical trial of laparoscopic versus open fundoplication: blind evaluation of recovery and discharge period. Br J Surg 2000;87:873–8
    1. Jolley SG, Tunell WP, Leonard JC, et al. Gastric emptying in children with gastroesophageal reflux. II. The relationship to retching symptoms following antireflux surgery. J Pediatr Surg 1987;22:927–30
    1. Baerg J, Thorpe D, Bultron G, et al. A multicenter study of the incidence and factors associated with redo Nissen fundoplication in children. J Pediatr Surg 2013;48:1306–11
    1. Richards CA, Andrews PL, Spitz L, et al. Nissen fundoplication may induce gastric myoelectrical disturbance in children. J Pediatr Surg 1998;33:1801–5
    1. Jolley SG, Tunell WP, Leonard JC, et al. Gastric emptying in children with gastroesophageal reflux. II. The relationship to retching symptoms following antireflux surgery. J Pediatr Surg 1987;22:927–30
    1. Lindeboom MY, Ringers J, van Rijn PJ, et al. Gastric emptying and vagus nerve function after laparoscopic partial fundoplication. Ann Surg 2004;240:785–90
    1. St Peter SD, Barnhart DC, Ostlie DJ, et al. Minimal vs extensive esophageal mobilization during laparoscopic fundoplication: a prospective randomized trial. J Pediatr Surg 2011;46:163–8
    1. Srivastava R, Downey EC, Feola P, et al. Quality of life of children with neurological impairment who receive a fundoplication for gastroesophageal reflux disease. J Hosp Med 2007;2:165–73
    1. Engelmann C, Gritsa S, Gratz KF, et al. Laparoscopic anterior hemifundoplication improves key symptoms without impact on GE in children with and children without neurodevelopmental delays. J Pediatr Gastroenterol Nutr 2010;51:437–42

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