One- and ten-year outcome of laparoscopic anterior 120° versus total fundoplication: a double-blind, randomized multicenter study.

Abstract

Nissen fundoplication is an effective treatment for gastroesophageal reflux disease (GERD) but can cause adverse effects like flatulence and dysphagia. The aim was to compare laparoscopic anterior 120° fundoplication (APF) to total fundoplication (Nissen) concerning flatulence and other adverse effects, in a randomized blinded study. Seventy-two patients were randomized to APF (n = 36) or Nissen (n = 36). Gastroscopy, 24-h pH monitoring and evaluation for symptoms and quality of life using questionnaires (GSRS, PGWB and 7-graded Likert scales) were performed preoperatively, at 1 and 10 years postoperatively. Patients and the researchers were blinded to operative method. When entering the study, most patients had mild-moderate reflux disease according to the symptom score, the 24-h pH measurements, and frequency and grade of esophagitis. At 1-year (n = 68) flatulence, dysphagia, heartburn and acid regurgitation did not differ between groups. More patients could belch (p = 0.005), and pH monitoring showed a higher time with pH < 4 in the APF group (p = 0.006). At 10 years (n = 61), the APF group reported less dysphagia (p < 0.001), more heartburn (p = 0.019) and more patients could belch (p = 0.012) and vomit (p < 0.001) compared to the Nissen. No difference remained at 10 years in pH monitoring (n = 23) between groups. Symptoms of heartburn and acid regurgitation were less than preoperatively in both groups (p < 0.001). No revisional operations were performed. Both procedures offer good long-term control of reflux symptom, with modest post-fundoplication symptoms. Anterior 120° fundoplication results in less dysphagia, better ability to belch and vomit than total fundoplication at 10-year follow-up. The results suggest that APF could be an alternative to Nissen fundoplication in the surgical treatment of mild-moderate GERD.