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316  Gastro-oesophageal Reflux Disease

        significant difference between those treated medically and those treated   The main adverse determinants of outcome seem to be the presence
               33
        surgically.  The incidence in children is difficult to establish.   of  neurological  impairment,  the  presence  of  associated  congenital
           A mortality risk exists for children having Nissen fundoplication. Most   anomalies, and stricture.
        of the mortality is late and due to associated conditions. Bradnock et al.,   Barrett’s oesophagus is a precursor to malignant adenocarcinoma of
        in their series of 85 patients, found a late mortality of 7% in children who   the oesophagus. Endoscopic surveillance is advocated in older children
                                    53
        underwent laparoscopic fundoplication.  A similar rate of mortality was   into  adulthood.  The  incidence  of  carcinoma  in  those  diagnosed  in
                         51
        reported by Tovar et al  in their series of 252 children who had either   childhood is not well established.
        open  or  laparoscopic  fundoplication.  In  that  series,  17  deaths  (6.7%)   Prevention
        occurred; 3 in the first postoperative month, with only 1 (0.4%) related
        to the operation.                                      There are no known preventive measures.
                     Prognosis and Outcomes                                Evidence-Based Research
                                                               Tables 49.3 and 49.4 present trial studies on thickened-feed interventions
        In patients with mild disease that resolves on conservative management or
                                                               in infants and a comparison of laparoscopic and open fundoplication in
        with pharmacotherapy with no recurrence, the outcome is good. Resolution
                                  54
        in infants usually takes 3 to 6 months.  Those with more severe symptoms   children, respectively.
                                                55
        may have ongoing disease even if improvement is noted.
        Table 49.3: Evidence-based research.                     Table 49.4: Evidence-based research.
           Title      The effect of thickened-feed interventions on   Title   Clinical outcome after open and laparoscopic Nissen
                      gastroesophageal reflux in infants: systematic review and   fundoplication in children: randomised controlled trial
                      meta-analysis of randomised, controlled trials
                                                                   Authors    McHoney M, Eaton S, Drake DP, Kiely EM, Curry J, Spitz L,
           Authors    Horvath A, Dziechciarz P, Szajewska H                   Pierro A
           Institution  Department of Paediatrics, Medical University of Warsaw,   Institution  Great Ormond Street Hospital for Children, London, UK
                      Warsaw, Poland
                                                                   Reference  Abstract Canadian Association of Pediatric Surgery
           Reference  Pediatrics 2008; 122:e1268–e1277                        Conference, October 2004
           Problem    Currently, thickened feeds are increasingly being used to   Problem  There have been no randomised controlled studies comparing
                      treat infants with gastro-oesophageal reflux, driven in large   the outcome between open and laparoscopic fundoplication
                      part by the baby food industry. Previous meta-analyses   in children. The aim of this study was to compare the clinical
                      have shown that although thickened formulas do not seem   outcome in children undergoing Nissen fundoplication who
                      to reduce measurable reflux, they may reduce vomiting.   were randomised to open surgery or laparoscopy.
                      However, because data are limited, there is still uncertainty
                      regarding the use of thickening agents.      Intervention  Randomised to open and laparoscopic Nissen fundoplication.
                                                                   Comparison/  Randomised control trial.
           Intervention  Meta-analysis of randomised controlled trials.
                                                                   control
           Comparison/  The Cochrane Library, Medline, Embase, and CINAHL   (quality of
           control    databases and proceedings of the European and North   evidence)
           (quality of   American paediatric gastroenterology conferences (from
                      2000) were searched in May 2008; additional references
           evidence)                                               Outcome    Twenty patients in the open and 19 patients in the
                      were obtained from reviewed articles. Only randomised,   effect  laparoscopic group. Median time to establish full feeds was
                      controlled trials that evaluated thickened feeds used in   2 days in both groups. Median hospital stay was 4.5 days
                      infants for at least several days for the treatment of gastro-  in the open group versus 5 days in the laparoscopic group,
                      oesophageal reflux were considered for inclusion. Three   with no significant difference between groups. There was
                      reviewers independently performed data extraction by using   no significant difference in morphine requirements, although
                      standard data-extraction forms. Discrepancies between   pain scores fell significantly faster in the laparoscopy group.
                      reviewers were resolved by discussion among all authors.   Incidence of dysphagia, recurrence of reflux, and need for
                      Only the consensus data were entered.                   redo fundoplication were not significantly different between
           Outcome    Fourteen randomised, controlled trials with a parallel or   groups. At the time of follow-up, the incidence of retching was
                                                                              higher after open surgery (56%) versus laparoscopy (6%; p =
           effect     crossover design, some with methodologic limitations,   0.003).
                      were included. Use of thickened formulas compared with
                      standard formula significantly increased the percentage of   Historical   This randomised trial demonstrated equal efficacy between
                      infants with no regurgitation, slightly reduced the number of   significance/  laparoscopic and open fundoplication in children.
                      episodes of regurgitation and vomiting per day (assessed   comments
                      jointly or separately), and increased weight gain per day.
                      It had no effect on the reflux index, number of acid gastro-
                      oesophageal reflux episodes per hour, or number of reflux
                      episodes lasting >5 minutes, but significantly reduced
                      the duration of the longest reflux episode of pH <4. No
                      definitive data showed that one particular thickening agent
                      is more effective than another. No serious adverse effects
                      were noted.
         Historical   Thickened food is moderately effective in treating gastro-
         significance/  oesophageal reflux in healthy infants.
         comments
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