Randomized controlled trial comparing Nissen fundoplication and the Angelchik prosthesis.

Sixty-one patients with gastro-oesophageal reflux refractory to medical therapy were entered into a prospective randomized trial comparing the Rossetti-Hell modification of the Nissen fundoplication (n = 31) with the Angelchik prosthesis (n = 30). Mean age, sex ratio, duration of symptoms, preoperative pH profiles and manometric findings were similar in the two groups. At a mean of 84 (range 64-105) months after closure of the trial 47 patients were available for review, eight had died from unrelated causes and six were lost to follow-up. Of the patients reviewed, 28 consented to endoscopy, 25 to oesophageal 24-h pH assessment and 20 to oesophageal manometry. Both fundoplication and the Angelchik prosthesis provided lasting control of gastro-oesophageal reflux, with 20 and 17 patients respectively maintaining a satisfactory outcome. There were no significant differences in pH profile between the groups but the Angelchik prosthesis had to be removed from three patients.