Randomized clinical trial of laparoscopic versus open fundoplication for gastro-oesophageal reflux disease

Background: The aim of this study was to compare laparoscopic and open Nissen fundoplication for gastro-oesophageal reflux disease in a randomized clinical trial. Methods: Ninety-nine patients were randomized to either laparoscopic (52) or open (47) Nissen fundoplication. Patients with oesophageal dysmotility, those requiring a concurrent abdominal procedure and those who had undergone previous antireflux surgery were excluded. Independent assessment of dysphagia, heartburn and patients' satisfaction 1, 3, 6 and 12 months after surgery was performed using multiple standardized clinical grading systems. Objective measurement of oesophageal acid exposure and lower oesophageal sphincter pressure before and after surgery, and endoscopic assessment of postoperative anatomy, were performed. Results: Operating time was longer in the laparoscopic group (median 82 versus 46 min). Postoperative pain, analgesic requirement, time to solid food intake, hospital stay and recovery time were reduced in the laparoscopic group. Perioperative outcomes, postoperative dysphagia, relief of heartburn and overall satisfaction were equally good at all follow-up intervals. Reduction in oesophageal acid exposure, increase in lower oesophageal sphincter tone and improvement in endoscopic appearances were the same for the two groups. Conclusion: The laparoscopic approach to Nissen fundoplication improved early postoperative recovery, with an equally good outcome up to 12 months.