Randomized clinical trial of laparoscopic versus open Fundoplication

Background: The laparoscopic approach in antireflux surgery might have an impact on the patient's daily activities and well-being, Methods: Sixty patients were randomized to laparoscopic or open 360degrees fundoplication. Data were collected by questionnaires and interviews preoperatively, 1 month and 6 months after operation. Results: Five patients in the laparoscopic group were converted to open surgery. Psychological general well-being increased after surgery and reached norm values in both study groups. No significant differences were found between the two types of surgery in the per protocol analysis, while the domain self-control was significantly better after open surgery in the intention-to-treat analysis. There was improvement of diet and steep in both study groups: after 6 months, disturbed sleep was significantly more uncommon after open surgery. Dysphagia and flatulence were new symptoms that were reported after surgery. Overall perception of the results of the operation did not differ between the groups. Conclusions: Psychological general well-being, diet and sleep improved after both laparoscopic and open surgery. There were only small differences between the groups, but in some respects the results were better after open surgery.