Long-term efficacy of total (Nissen-Rossetti) and posterior partial (Toupet) fundoplication: results of a randomized clinical trial.

The efficacy of fundoplication operations in the long-term management of gastroesophageal reflux disease (GERD) has been documented. However, only a few prospective controlled series support the long-term (>10 years) efficacy of these procedures, and further data are required to also determine whether the type of fundoplication affects the frequency of postfundoplication complaints. The aim of this study was to conduct a randomized, controlled clinical trial to assess the long-term symptomatic outcome of a partial posterior fundoplication as compared to a total fundic wrap. During the years 1983 to 1991, a total of 137 patients with chronic gastroesophageal reflux disease were enrolled in the study; 72 were randomized to semifundoplication (Toupet) and 65 to total fundoplication (Nissen-Rossetti). A standardized symptom questionnaire was used for follow-up of these patients. A total of 110 patients completed a median follow-up of 11.5 years; 54 had a total wrap and 56 underwent a partial posterior fundoplication. During this period, seven patients required reoperation (Nissen-Rossetti in 5 and Toupet in 2), 11 patients died, and nine patients were lost to follow-up or did not comply with the follow-up program. Control of heartburn (no symptoms or mild, intermittent symptoms) was achieved in 88% and 92% in the total and partial fundoplication groups, respectively, and the corresponding figures for control of acid regurgitation were 90% and 94%. We observed no difference in dysphagia scoring between the two groups, although odynophagia was somewhat more frequently reported in those undergoing a total fundoplication. On the other hand, a significant difference was observed in the prevalence of rectal flatus and postprandial fullness, which were recorded significantly more often in those undergoing a total fundoplication (P < 0.001 and P < 0.03, respectively). Posterior partial fundoplication seems to maintain the same high level of reflux control as total fundoplication. Earlier observations demonstrating the advantages of a partial fundoplication, which included fewer complaints associated with gas-bloat, continue to be valid after more than 10 years of follow-up.

RCT Entities:   Population Interventions Outcomes