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

Background: Laparoscopic operation has replaced the conventional open proce dure in the treatment of gastroesophageal reflux disease (GERD) in spite of the fact that longterm results based on controlled clinical trials have be en lacking. The objective of this study was to compare outcome, quality of life, and patient satisfaction after laparoscopic and open Nissen fundoplic ation in a community hospital setting with a 2-year follow-up. Methods: Forty-two patients with GERD were randomized to either laparoscopi c (LNF) or open (ONF) Nissen fundoplication. Outcome evaluation included re flux symptoms, gastrointestinal quality of life (GIQLI), and upper GI endos copy. Results: Esophagitis was cured among all patients in the LNF group and in 9 0% of the ONF group. There were two patients (10%) in both groups who had m edicine-dependent recurrent reflux together with significant worsening in t he 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 (sc ale, 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 t he operation again. Conclusions: Laparoscopic and open Nissen fundoplication seem to be equally effective methods for improving reflux symptoms and quality of life, resul ting in a high rate of satisfaction among patients with an intermediate fol low-up period of 2 years.