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

Br J Surg. 2000 Jul;87(7):873-8. doi: 10.1046/j.1365-2168.2000.01471.x.

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 degrees 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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Arousal
  • Double-Blind Method
  • Female
  • Forced Expiratory Volume
  • Fundoplication / methods*
  • Gastroesophageal Reflux / surgery*
  • Humans
  • Laparoscopy / methods*
  • Length of Stay
  • Male
  • Middle Aged
  • Pain Measurement
  • Pain, Postoperative / etiology
  • Pain, Postoperative / prevention & control
  • Postoperative Care / methods
  • Prospective Studies
  • Sick Leave
  • Vital Capacity