Objective: To compare 10 years outcome of a multicenter randomized controlled trial on laparoscopic (LNF) and conventional Nissen fundoplication (CNF), with focus on effectiveness and reoperation rate.
Summary of background data: LNF has replaced CNF as surgical treatment for gastroesophageal reflux disease (GERD). Decisions are based on equal short-term effectiveness and reduced morbidity, but confirmation by long-term level 1 evidence is lacking.
Methods: From 1997 to 1999, 177 proton pump inhibitor (PPI)-refractory GERD patients were randomized to undergo LNF or CNF. The 10 years results of surgery on reflux symptoms, general health, PPI use, and reoperation rates, are described. High-resolution manometry, 24-hour pH-impedance monitoring and barium swallow were performed in symptomatic patients only.
Results: A total of 148 patients (79 LNF, 69 CNF) participated in this 10-year follow-up study. GERD symptoms were relieved in 92.4% and 90.7% (NS) after LNF and CNF, respectively. Severity of heartburn and dysphagia were similar, but slightly more patients had relief of regurgitation after LNF (98.7% vs. 91.0%; P = 0.030). The percentage of patients using PPIs slowly increased with time in both groups to 26.6% for LNF and 22.4% for CNF (NS). General health (74.7% vs. 72.7%; NS) and quality of life (visual analogue scale score: 65.3 vs. 61.4; NS) improved similarly in both groups. The percentage of patients who would have opted for surgery again was similar as well (78.5% vs. 72.7%; NS). Twice as many patients underwent reoperation after CNF compared with LNF (12 [15.2%] vs. 24 [34.8%]; P = 0.006), including a higher number of incisional hernia corrections (2 vs. 9; P = 0.015). Mean interval between operation and reintervention was longer after CNF (22.9 vs. 50.6 months; P = 0.047). Of the patients who were dependent on daily PPI therapy at 10 years (LNF 10, CNF 10), 7 patients (LNF 3, CNF 4) had recurrent GERD on pH-impedance monitoring, 5 of them with some form of anatomic recurrence. A total of 13 of 20 (65.0%) patients did not have recurrent GERD. Fourteen patients had an abnormal high-resolution manometry.
Conclusions: CNF carries a higher risk for surgical reintervention compared with LNF, mainly due to incisional hernia corrections. The 10-year effectiveness of LNF and CNF is comparable in terms of improvement of GERD symptoms, PPI use, quality of life, and objective reflux control. Consequently, the long-term results from this trial lend level 1 support to the use of LNF as the surgical procedure of choice for GERD.