Comparison of laparoscopic and open Nissen fundoplication 2 years after operation - A prospective randomized trial

Background: Laparoscopic operation has replaced the conventional open procedure in the treatment of gastroesophageal reflux disease (GERD) in spite of the fact that longterm results based on controlled clinical trials have been lacking. The objective of this study was to compare outcome, quality of life, and patient satisfaction after laparoscopic and open Nissen fundoplication in a community hospital setting with a 2-year follow-up. Methods: Forty-two patients with GERD were randomized to either laparoscopic (LNF) or open (ONF) Nissen fundoplication. Outcome evaluation included reflux symptoms, gastrointestinal quality of life (GIQLI), and upper GI endoscopy. Results: Esophagitis was cured among all patients in the LNF group and in 90% of the ONF group. There were two patients (10%) in both groups who had medicine-dependent recurrent reflux together with significant worsening in the GIQLI scores. One patient in the LNF group has been reoperated due to a suture granuloma in the left epigastric port. Two patients in the LNF group needed esophageal dilatation due to persistent dysphagia, GIQLI scores (scale, 0-144) were equally normalized in both groups. Overall, 90% in the LNF and 100% in the ONF group were either satisfied or very satisfied with the operation. There was only one patient (LNF) who would not choose to have the operation again. Conclusions: Laparoscopic and open Nissen fundoplication seem to be equally effective methods for improving reflux symptoms and quality of life, resulting in a high rate of satisfaction among patients with an intermediate follow-up period of 2 years.