Five-year follow-up of a randomized clinical trial of laparoscopic total versus anterior 180 degrees fundoplication.

ABSTRACT

BACKGROUND: Total fundoplication for gastro-oesophageal reflux disease may be followed by unwanted side-effects. A randomized trial demonstrated that an anterior 180 degrees partial fundoplication achieved effective reflux control and was associated with fewer side-effects in the short term than total fundoplication. This paper reports longer-term (5 year) outcomes from that trial. METHODS: Between December 1995 and June 1997, 107 patients were randomized to undergo either laparoscopic total fundoplication or a laparoscopic anterior 180 degrees fundoplication. After 5 years, 101 of 103 eligible patients (51 total, 50 anterior) were available for follow-up. Each patient was interviewed by a single blinded investigator and a standardized questionnaire was completed. The questionnaire focused on symptoms and overall satisfaction with the results of fundoplication. RESULTS: There were no significant differences between the two groups with regard to control of heartburn or patient satisfaction with the overall outcome. Dysphagia, measured by a visual analogue score for solid food and a composite dysphagia score, was worse at 5 years after total fundoplication. Symptoms of bloating, inability to belch and flatulence were also more common after total fundoplication. Reoperation was required for dysphagia in three patients after total fundoplication and for recurrent reflux in three patients after anterior fundoplication. CONCLUSION: Anterior 180 degrees partial fundoplication was as effective as total fundoplication for managing the symptoms of gastro-oesophageal reflux in the longer term. It was associated with a lower incidence of side-effects, although this was offset by a slightly higher risk of recurrent reflux symptoms.