Randomized prospective trial of the Angelchik anti-reflux prosthesis.
Fifty-two patients with reflux oesophagitis resistant to medical treatment were randomized at operation to receive either the Angelchik prosthesis or a fundoplication. All patients were assessed postoperatively by a physician unaware of the nature of the operation. Forty-two patients have been followed up for 1-2 years; ten patients for 3-9 months. Ninety-six per cent of the Angelchik patients had satisfactory or excellent results compared with 81 per cent with a fundoplication. There were no failures to control reflux with the Angelchik prosthesis whereas 6 patients (23 per cent) of the fundoplication group have persisting reflux. Operating times for insertion of the prosthesis averaged a little over half that recorded for fundoplication. Complication rates were similar. The results of the trial encourage the use of the prosthesis in patients with gastro-oesophageal reflux, where medical treatment has failed. The prosthesis should not be used if the gut is opened during operation either inadvertently or deliberately, as in making a suture line or anastomosis, because of the risk of sepsis.
D002986:Clinical Trials as Topic; D004942:Esophagitis, Peptic / Q000601:surgery*; D004947:Esophagus / Q000601:surgery; D005260:Female; D005748:Gastric Fundus / Q000601:surgery; D006551:Hernia, Hiatal / Q000601:surgery; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D011446:Prospective Studies; D019736:Prostheses and Implants; D011897:Random Allocation