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

Abstract

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. Sixty patients with gastro-oesophageal reflux disease were randomized to open or laparoscopic 360 degrees fundoplication. The type of operation was unknown to the patient and the evaluating nurses after operation. 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. 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.