Long-term results of antireflux surgery indicate the need for a randomized clinical trial

Background: Well conducted, comparative trials of laparoscopic versus open antireflux surgery with an adequate patient enrolment are few and they do not demonstrate obvious advantages for the laparoscopic approach except for a marginal gain in shorter hospital stay. The aim of this study was to compare the effectiveness of laparoscopic and open procedures. Methods: Two unselected groups of 230 patients were identified through a register of all inpatient public care in Sweden. Outcomes of laparoscopic and open antireflux surgery were compared using a disease-specific questionnaire 4 years after operation. Results: Failure and dissatisfaction were significantly more common in the laparoscopy group than among patients having conventional open surgery. Treatment failure rates were 29.0 and 14.6 per cent respectively (P = 0.004). Dissatisfaction rates were 15.0 and 7.0 per cent respectively (P = 0.005). There was no other questionnaire item for which the proportion of failures differed significantly between the two groups. Conclusion: This study does not support the presumption that laparoscopic antireflux surgery is to be preferred to the open procedure. It is strongly recommended that a randomized controlled trial be conducted.