Single center prospective randomized trial of laparoscopic Nissen versus anterior 90 degrees fundoplication.

Although Nissen fundoplication is a very effective treatment for gastroesophageal reflux, it is associated with a small incidence of troublesome postoperative side effects. To prevent this, progressive modification of surgical techniques has led to the development of an anterior 90 degrees fundoplication. We undertook a prospective randomized trial to compare this procedure with Nissen fundoplication to determine whether it would achieve a better clinical outcome. Patients presenting to a single center for primary laparoscopic antireflux surgery were randomized to undergo either an anterior 90 degrees fundoplication (n = 40) or a Nissen fundoplication without division of the short gastric vessels (n = 39). Clinical questionnaires were used to assess outcome at 1 month, 3-6 months, and 12 months. Both patients and the clinical interviewer were masked as to which procedure was performed. Follow-up with endoscopy, esophageal manometry, and pH monitoring was also undertaken. Operating time was similar for the two procedures (60 minutes for anterior vs. 55 minutes for Nissen fundoplication). Early postoperative complications were more common after Nissen fundoplication (18% vs. 5%). Two patients underwent laparoscopic reoperation for recurrent reflux after anterior 90 degrees fundoplication, and four underwent laparoscopic reoperation after Nissen fundoplication (dysphagia, 3 patients; acute hiatus hernia, 1 patient). One year after surgery, dysphagia and other wind-related side effects were less common after anterior 90 degrees fundoplication. Control of reflux symptoms and satisfaction with the overall outcome was similar for the two procedures. Anterior 90 degrees fundoplication is followed by fewer side effects than Nissen fundoplication. This advantage is offset by a greater likelihood of reflux recurrence. However, this does not diminish patient satisfaction.

RCT Entities:   Population Interventions Outcomes