title: Randomized controlled trial comparing Nissen fundoplication and the Angelchik prosthesis.
abstract: 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.
authors.affiliation: Department of Surgery, St James's Hospital, Dublin, Ireland.
authors.forename: A D
authors.initials: AD
authors.lastname: Hill
authors.forename: T N
authors.initials: TN
authors.lastname: Walsh
authors.forename: C M
authors.initials: CM
authors.lastname: Bolger
authors.forename: P J
authors.initials: PJ
authors.lastname: Byrne
authors.forename: T P
authors.initials: TP
authors.lastname: Hennessy
mesh_terms: D004943:Esophagogastric Junction / Q000503:physiopathology; D004947:Esophagus / Q000601:surgery*; D005260:Female; D005748:Gastric Fundus / Q000601:surgery*; D005764:Gastroesophageal Reflux / Q000503:physiopathology / Q000601:surgery*; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D011312:Pressure; D011446:Prospective Studies; D019736:Prostheses and Implants