Late results of a randomized clinical trial comparing total fundoplicationversus calibration of the cardia with posterior gastropexy

Background: The aim was to perform a prospective randomized study in patien ts with chronic gastrooesophageal reflux treated either by total fundoplica tion or calibration of the cardia with posterior gastropexy. Late follow-up considered subjective and objective parameters, and related outcome to the presence of Barrett's oesophagus. Methods: A total of 164 patients were randomized to fundoplication (n = 76) or calibration of the cardia (n = 88). They were evaluated by clinical que stionnaire, upper gastrointestinal endoscopy with biopsies, oesophageal man ometry and gastro-oesophageal reflux studies, including scintigraphy and 24 -h oesophageal pH monitoring. Results: There were no operative deaths. There was 95 per cent follow-up at a mean of 85 months. The mean recurrence rate for both operations was near 40 per cent at 10 years, but patients without Barrett's oesophagus had a r ecurrence rate after both operations of around 23 per cent compared with 83 per cent after 10 years for those with Barrett's oesophagus (P < 0.0001). Low-grade dysplasia developed in 13 per cent of the patients with Barrett's oesophagus. There were significant differences in all objective parameters in a comparison of patients with Visick I or II and those with Visick III or IV disease at the late assessment. Conclusion: Both total fundoplication and calibration of the cardia with po sterior gastropexy had similar subjective and objective late results. Howev er, results were significantly worse in patients with Barrett's oesophagus.