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Randomized Controlled Trial
. 2014 Jun;99(6):516-21.
doi: 10.1136/archdischild-2013-304279. Epub 2014 Feb 14.

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

Maurizio Pacilli  1 , Simon Eaton  1 , Merrill McHoney  1 , Edward M Kiely  1 , David P Drake  1 , Joseph I Curry  1 , Keith J Lindley  2 , Agostino Pierro  1
Affiliations
Free PMC article
Randomized Controlled Trial

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

Maurizio Pacilli et al. Arch Dis Child. 2014 Jun.
Free PMC article

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.

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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).
See this image and copyright information in PMC

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 - PubMed
    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 - PubMed
    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 - PMC - PubMed
    1. Kimber C, Kiely EM, Spitz L. The failure rate of surgery for gastro-oesophageal reflux. J Pediatr Surg 1998;33:64–6 - PubMed
    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 - PubMed

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