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.
Hill
A D
AD
Department of Surgery, St James's Hospital, Dublin, Ireland.
Walsh
T N
TN
Bolger
C M
CM
Byrne
P J
PJ
Hennessy
T P
TP
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