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.
RCT Entities:
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.
Authors: Pascual Parrilla; Luisa F Martínez de Haro; Angeles Ortiz; Vicente Munitiz; Andres Serrano; Gloria Torres Journal: Ann Surg Date: 2003-04 Impact factor: 12.969
Authors: Marco Catarci; Paolo Gentileschi; Claudio Papi; Alessandro Carrara; Renato Marrese; Achille Lucio Gaspari; Giovanni Battista Grassi Journal: Ann Surg Date: 2004-03 Impact factor: 12.969
Authors: Eugene Y Chang; Cynthia D Morris; Ann K Seltman; Robert W O'Rourke; Benjamin K Chan; John G Hunter; Blair A Jobe Journal: Ann Surg Date: 2007-07 Impact factor: 12.969