A prospective randomized trial on laparoscopic total vs partial fundoplication in patients with atypical symptoms of gastroesophageal reflux disease.

ABSTRACT

BACKGROUND: Currently very little is known about the impact of anti-reflux surgery on extra-esophageal manifestations of gastroesophageal reflux disease (GERD) when compared with the typical symptoms of reflux. The aim of our study was to evaluate the clinical effect of total (360°) and partial (270°) laparoscopic fundoplication on extraesophageal GERD symptoms. METHODS: One hundred and twenty patients with documented extraesophageal GERD symptoms were randomized to either undergo floppy Nissen (n= 60) or Toupet fundoplication (n= 60). Symptom scores of throat clearing, globus sensation, cough, throat pain, and vocal changes were prospectively evaluated. A reflux symptom index (RSI) questionnaire was used to accurately document the improvement of extraesophageal symptoms. Quality of life was determined according to the laryngopharyngeal reflux-health-related quality of life (LPR-HRQL) questionnaire. RESULTS: No significant differences were identified between the groups regarding demographic data, such as age, gender, or body mass index. The median RSI score before operation and at 24-month follow-up was 22.8 ± 5.3 and 10.4 ± 5.4 respectively in the laparoscopic Nissen fundoplication (LNF) group (p < 0.05) and 21.7 ± 5.0 and 11.6 ± 5 respectively in the laparoscopic Toupet fundoplication (LTF) group (p < 0.05). The median LPR-HRQL score in the LNF group improved from 42.9 ± 13.8 before treatment to 10.7 ± 6.5 at 24 months (p < 0.05). In the LTF group, there was an improvement in the median LPR-HRQL score from 40.4 ± 10.9 prior to treatment to 11.7 ± 5.7 at 24 months (p < 0.05). The median RSI score and LPR-HRQL scores were similar between the groups at follow-up (p > 0.05). CONCLUSIONS: Our report demonstrates that LNF and LTF provide equivalently good results for patients with extraesophageal manifestations of GERD. Quality of life is similar after LNF and LTF.