Randomized clinical trial of laparoscopic versus open fundoplication: blind evaluation of recovery and discharge period

Abstract

Background: There is a widespread belief that introduction of the laparoscopic technique in antireflux surgery has led to easier postoperative recovery. To test this hypothesis a prospective randomized clinical trial with blind evaluation was conducted between laparoscopic and open fundoplication. Methods: Sixty patients with gastro-oesophageal reflux disease were randomized to open or laparoscopic 360° fundoplication. The type of operation was unknown to the patient and the evaluating nurses after operation. Results: The operating time was longer in the laparoscopy group, median 148 versus 109 min (P < 0·0001). The need for analgesics was less in the laparoscopically operated patients, 33·9 versus 67·5 mg morphine per total hospital stay (P < 0·001). There was no significant difference in postoperative nausea and vomiting. On the first day after operation patients in the laparoscopy group had better respiratory function: forced vital capacity 3·2 versus 2·2 litres (P = 0·004) and forced expiratory volume 2·6 versus 2·0 litres (P = 0·008). Postoperative hospital stay was shorter in the laparoscopic group, median (range) 3 (2–6) versus 3 (2–10) days (P = 0·021). No difference was found in the duration of sick leave. Conclusion: Laparoscopic fundoplication was associated with a longer operating time, better respiratory function, less need for analgesics and a shorter hospital stay, while no reduction in the duration of postoperative sick leave was found compared with open surgery.