title: Four year follow-up of a randomised controlled trial comparing open and laparoscopic Nissen fundoplication in children.
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.
  
  
  BACKGROUND
  NCT00259961.
authors.affiliation: Department of Surgery, Institute of Child Health and Great Ormond Street Hospital, University College London, London, UK.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Pacilli
authors.affiliation: Department of Surgery, Institute of Child Health and Great Ormond Street Hospital, University College London, London, UK.
authors.forename: Simon
authors.initials: S
authors.lastname: Eaton
authors.affiliation: Department of Surgery, Institute of Child Health and Great Ormond Street Hospital, University College London, London, UK.
authors.forename: Merrill
authors.initials: M
authors.lastname: McHoney
authors.affiliation: Department of Surgery, Institute of Child Health and Great Ormond Street Hospital, University College London, London, UK.
authors.forename: Edward M
authors.initials: EM
authors.lastname: Kiely
authors.affiliation: Department of Surgery, Institute of Child Health and Great Ormond Street Hospital, University College London, London, UK.
authors.forename: David P
authors.initials: DP
authors.lastname: Drake
authors.affiliation: Department of Surgery, Institute of Child Health and Great Ormond Street Hospital, University College London, London, UK.
authors.forename: Joseph I
authors.initials: JI
authors.lastname: Curry
authors.affiliation: Gastroenterology Units, Institute of Child Health and Great Ormond Street Hospital, University College London, London, UK.
authors.forename: Keith J
authors.initials: KJ
authors.lastname: Lindley
authors.affiliation: Department of Surgery, Institute of Child Health and Great Ormond Street Hospital, University College London, London, UK.
authors.forename: Agostino
authors.initials: A
authors.lastname: Pierro
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D005260:Female; D005500:Follow-Up Studies; D018662:Fundoplication / Q000379:methods*; D005764:Gastroesophageal Reflux / Q000601:surgery*; D006801:Humans; D007223:Infant; D010535:Laparoscopy / Q000379:methods*; D008297:Male; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
keywords: Gastroenterology; Paediatric Surgery; Procedures