Randomized Trial of Laparoscopic Nissen vs. Anterior 180 Degree Partial Fundoplication - Late Clinical Outcomes at 15-20 years.

OBJECTIVE To determine very late clinical outcomes at up to 20 years follow-up from a randomized controlled trial of Nissen vs. anterior 180-degree partial fundoplication. SUMMARY BACKGROUND DATA Nissen fundoplication for gastroesophageal reflux can be followed by troublesome side effects. To address this, partial fundoplications have been proposed. Previously reports from a randomized controlled trial of Nissen vs. anterior 180-degree partial fundoplication at up to 10 years follow-up showed good outcomes for both procedures. METHODS 107 participants were randomized to Nissen vs. anterior 180-degree partial fundoplication. 15-20 year follow-up data was available for 79 (41 Nissen, 38 anterior). Outcome was assessed using a standardized questionnaire with 0-10 analogue scores and yes/no questions to determine reflux symptoms, side-effects and satisfaction with surgery. RESULTS After anterior fundoplication heartburn (mean score 3.2 vs 1.4, p = 0.001) and proton pump inhibitor use (41.7% vs 17.1%, p = 0.023) were higher, offset by less dysphagia for solids (mean score 1.8 vs 3.3, p = 0.015), and better ability to belch (84.2% vs 65.9%, p = 0.030). Measures of overall outcome were similar for both groups (mean satisfaction score 8.4 vs 8.0, p = 0.444; 86.8% vs 90.2% satisfied with outcome). Six participants underwent revision following anterior fundoplication (Nissen conversion for reflux - 6), and 7 underwent revision following Nissen fundoplication (Nissen to partial fundoplication for dysphagia - 5; redo Nissen for reflux - 1; paraesophageal hernia -1). CONCLUSIONS At 15-20 years follow-up Nissen and anterior 180-degree partial fundoplication achieved similar success, but with trade-offs between better reflux control vs. more side-effects after Nissen fundoplication.