Results of a prospective randomized trial of the Angelchik prosthesis and of a consecutive series of 119 patients.

The results of a randomized multicentre trial comparing the Angelchik prosthesis with floppy Nissen fundoplication for gastro-oesophageal reflux were assessed 4-6 years after surgery. Of the original 52 patients 48 were traced. A good or excellent result (Visick grade 1 or 2) was obtained in 21 of 25 after insertion of the Angelchik prosthesis compared with 18 of 23 after fundoplication. Poor results were due to recurrent heartburn after fundoplication and to dysphagia after prosthesis insertion. In a separate consecutive series of 119 patients receiving Angelchik prostheses, results were good or excellent in 101 (85 per cent) and poor in 18 (15 per cent). Control of reflux with a correctly positioned prosthesis was good. Troublesome dysphagia (Visick grade 3 or 4) was experienced in eight of the 119 patients. There was no mortality and no incidence of splenectomy or gas-bloat syndrome.

RCT Entities:   Population Interventions Outcomes