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

Abstract

Abstract Background The aim was to perform a prospective randomized study in patients with chronic gastro-oesophageal reflux treated either by total fundoplication 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 questionnaire, upper gastrointestinal endoscopy with biopsies, oesophageal manometry 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 recurrence 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 posterior gastropexy had similar subjective and objective late results. However, results were significantly worse in patients with Barrett's oesophagus.