Summary Background Laparoscopic Nissen fundoplication is considered the gold standard in surgical management of gastroesophageal reflux disease. Therefore, exhaustive scrutiny of the procedure is necessary. The aim of this study was to perform a complete and systematic literature review of laparoscopic Nissen fundoplication to summarize the evidence for safety and efficacy over time. Methods MEDLINE, Embase, CINAHL, the Cochrane Library, and Web of Science were searched for randomized controlled trials investigating intra- and postoperative outcomes at follow-ups between 4–6 weeks and 17 years. Results Among 1675 screened articles, 63 articles were identified comprising 40 trials with a total of 2619 participants. Intraoperative events included bleeding (2.9%), gastroesophageal injury/perforation (0.9%), and spleen injury/splenectomy (0.9%). One-year clinical follow-up presented the following: dysphagia (22.4%), heartburn or epigastric/sternal pain (15.1%), gas bloating (30.1%), and inability to vomit/belch (16.4%). These outcomes displayed a U-shaped curve with a minimum of symptoms at 1 year. At 10 years postoperatively, clinical outcomes deteriorated, demonstrating dysphagia (45.3%), heartburn or epigastric/sternal pain (30.9%), inability to vomit/belch (48.8%), and gas bloating (44.4%). Furthermore, the surgical benefit seems to dissipate at 17 years. At 1 and 10 years after surgery, reoperation rates were 6.7% and 16.3%, whereas proton pump inhibitor (PPI) use was at 12.3% and 23.3%, respectively. Conclusion The performance of Nissen fundoplication declines over time, as demonstrated by increased PPI medication usage for recurrent symptoms and an increased reoperation rate reaching a combined 39.6%, representing failures after 10 years. The complication rates are dominated by dysphagia, gas bloating, inability to belch/vomit, and/or recurrent reflux symptoms with heartburn.
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