Background: Several studies, most of them nonrandomized, have shown similar functional results for both laparoscopic and open Nissen fundoplication, the operation of choice for the treatment of gastroesophageal reflux disease (GERD). Methods: A total of 106 patients with documented GERD were randomized to receive either a laparoscopic or an open Nissen fundoplication. Preoperative and postoperative investigations included clinical assessment, esophagogram, upper gastrointestinal endoscopy, esophageal manometry, and 24-h ambulatory pHmetry. Results: Both approaches were successful in controlling reflux. There was an overall improvement in esophageal peristalsis and an increase in lower esophageal sphincter (LES) pressure in both groups. Open Nissen fundoplication was associated with a significantly increased rate of wound (p < 0.001) and respiratory (p < 0.05) complications. Hospitalization was also longer after the open technique (p < 0.001). At 3-month follow-up, although the rate of postoperative dysphagia was similar for the two approaches, the open approach was associated with a significantly higher incidence of postprandial epigastric fullness (p < 0.05) and bloating syndrome (p < 0.01). Conclusions: The open and laparoscopic approaches for the Nissen fundoplication are equally effective in controlling GERD. The open approach is associated with a significantly higher rate of wound and respiratory complications and, at early stages, an increased rate of postprandial epigastric fullness and abdominal bloating. The dysphagia rate is similar with both methods.
