Prospective randomized trial of Nissen fundoplication and Angelchik prosthesis in the surgical treatment of medically refractory gastro-oesophageal reflux disease

Abstract

Fifty patients with gastro-oesophageal reflux disease refractory to multiple courses of medical therapy were entered into a prospective randomized trial comparing Nissen fundoplication with the Angelchik prosthesis as a primary surgical procedure. The two groups were matched for age, sex, duration of symptoms before surgery, type of medical therapy, pattern of symptom presentation, endoscopic grade of oesophageal inflammation, manometric lower oesophageal pressure and 24-h pH profile. Twenty-five patients were randomized to each of the Nissen fundoplication and Angelchik prosthesis groups. Operation time and hospital stay were similar in both groups. Persistent dysphagia was reported in five of the patients with an Angelchik prosthesis compared with none in the Nissen fundoplication group. Three prostheses were removed because of severe dysphagia while no Nissen fundoplication required revision. No patient with preoperative dysphagia because of stricture reported swallowing difficulties after operation. At clinical assessment at 3, 6, 12 and 24 months after operation, 85–88 per cent of the patients having a Nissen fundoplication were graded Visick 1 or 2 compared with 60–72 per cent of patients in the Angelchik group.