Total or Posterior Partial Fundoplication in the Treatment of GERD Results of a Randomized Trial After 2 Decades of Follow-up

Objective and Background: We lack long-term data (> 10 years) on the efficacy of antireflux surgery when evaluated within the framework of randomized clinical trials Hereby we report the outcome of a randomized trial comparing open total (I) and a Toupet posterior partial fundoplication (II) performed between 1983 and 1991. Methods: One hundred and thirty-seven patients with gastroesophageal reflux disease and were enrolled into the study. The mean follow up has now reached 18 years. During these years 26% had died and 16% were unable to trace for follow up. Symptom outcomes were assessed by the use of validated self-reporting questionnaires. Results: Long-termcontrol of heartburn and acid regurgitation (reported as no or mild symptoms) were reported by 80% and 82% after a total fundoplication (I) and corresponding figures were 87% and 90% after a partial posterior fundoplication (II), respectively (n.s.). The dysphagia scores were low 4.6 +/- 1.3 (SEM) in group I and 3.3 +/- 0.9 (SEM) in group II (n.s). The point prevalences of rectal flatulence and gas distension related complaints were of similar magnitude in the 2 groups. Twenty-three percentage of the patients in the total fundoplication group noted some ability to vomit compared with 31% in the partial posterior fundoplication group. Conclusions: Both a total and a partial posterior fundoplication maintain a high level of reflux control after 2 decades of follow up. The previously reported differences in mechanical side effects, in favor of the partial wrap, seemed to disappear over time. ISRCTN59614486 http://www.controlled-trials.com/ISRCTN59614486/