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

Abstract

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.