Abstract
BACKGROUND/OBJECTIVE: Laparoscopic fundoplication for gastroesophageal reflux disease (GERD) is one of the most common procedures performed in children. A critical literature review was performed to evaluate the level and quality of evidence supporting the efficacy of this procedure.METHODS: Systematic reviews of the EMBASE, PubMed and CENTRAL databases were conducted to retrieve all articles published over a 15-year period (1996 to 2010) reporting medium- to long-term outcomes (minimum six months follow-up) of laparoscopic fundoplication for the treatment of pediatric GERD. Articles were critically appraised using the Newcastle-Ottawa quality assessment scale and the Cochrane risk of bias assessment tool. Extracted outcomes included GERD recurrence, need for reoperation, postoperative morbidity and mortality.RESULTS: A total of 5302 articles were retrieved. Thirty-six studies met inclusion and exclusion criteria, including five prospective (level 2b), four retrospective comparative (level 3b) and 27 case series (level 4). No studies compared laparoscopic fundoplication with medical treatment. Thirty-six per cent of studies did not describe the symptoms used to suspect GERD; 11% did not disclose the diagnostic modalities used; and 41% did not report the findings of diagnostic modalities. Only 17% of studies provided a definition of recurrence, and only 14% attempted to control for confounding variables. The follow-up intervals were inconsistently reported, ranging between two months and nine years. Significant heterogeneity among studies limited the ability to pool outcomes. Mean (± SD) recurrence rates varied between 0% and 48±19.6% of patients. Reoperation was required in 0.69±0.95% to 17.7±8.4% of patients. Mortality ranged between 0% and 24±16.7%.CONCLUSION: The level and quality of the evidence supporting laparoscopic fundoplication are extremely poor. Higher-quality data are required before the procedure can be considered to be an effective intervention in the treatment of pediatric GERD.