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Gastroesophageal reflux disease (GERD) is often associated with hiatal hernia (HH). However, the need for fundoplication during hiatal hernia repair (HHR) remains controversial. The objective of this study was to evaluate the effect of HHR with concomitant laparoscopic Nissen fundoplication (HHR-LNF) in HH patients. A total of 122 patients with symptomatic HH were randomized to receive either HHR (n = 61) or HHR-LNF (n = 61). The measures of evaluating outcomes included DeMeester scores (DMS), complications, Reflux Diagnostic Questionnaire and patients’ satisfaction 24 months following surgery. Despite comparable values in both groups at randomization, the DMS, total numbers of reflux episodes and percentage of time with pH < 4 were significantly higher in HHR group than in HHR-LNF group ( P  = 0.017,  P  = 0.002 and  P  = 0.019, respectively) at 6 months after surgery. One months postoperatively, complications were higher in the HHR-LNF group than in the HHR group (all  P  < 0.001), and there was no difference between the two groups at 6 months. By the end of the 2-year follow-up, HHR-LNF group showed a significantly lower reflux syndrome frequency-intensity score and greater percentage of satisfaction compared with HHR group (all  P  < 0.001). Laparoscopic HHR should be combined with a fundoplication in GERD patients with HH. HHR-LNF is safe and effective, not only improve reflux-related symptom, but also reduce the incidence of complications.

Role of fundoplication in treatment of patients with symptoms of hiatal hernia