Randomized clinical trial of laparoscopic versus open fundoplication for gastro-oesophageal reflux.

BACKGROUND: The aim of this study was to compare the long-term results of laparoscopic and open antireflux surgery in a randomized clinical trial by investigating subjective and objective outcomes.

METHODS: Sixty patients with gastro-oesophageal reflux disease (GORD) were randomized to laparoscopic or open 360 degrees fundoplication. Subjective evaluation using disease-specific and generic questionnaires and structured interviews, and objective evaluation by endoscopy, oesophageal manometry and 24-h pH monitoring, were performed before operation and 1 month, 6 months and 5 years after surgery.

RESULTS: Two patients in the laparoscopic group had reoperations for hiatal stricture; one patient in the open group had repair of an incisional hernia, and one patient in each group had surgery for intestinal obstruction. There were no differences in the subjective outcomes of diet, sleep, medication, patient satisfaction and symptoms of GORD after 5 years. Nor were there any differences in objective outcomes determined by endoscopy, manometry or 24-h pH monitoring. Well-being was decreased in all patients before operation but was restored to normal or above-normal values after fundoplication, regardless of the type of surgery. Seven of 28 patients in the open group had complaints regarding the scar.

CONCLUSION: Elimination of GORD symptoms improved well-being and eliminated the need for daily acid suppression in most patients, no matter which procedure was employed. These results were apparent 1 month after the operation and were still valid 5 years later.