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Randomized Controlled Trial
Randomized Trial of Laparoscopic Nissen vs. Anterior 180 Degree Partial Fundoplication - Late Clinical Outcomes at 15-20 years.
- Victoria Rudolph-Stringer, Tim Bright, Tanya Irvine, Sarah K Thompson, Peter G Devitt, Philip A Game, Glyn G Jamieson, and David I Watson.
- Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, Australia.
- Ann. Surg. 2022 Jan 1; 275 (1): 39-44.
ObjectiveTo determine very late clinical outcomes at up to 20 years follow-up from a randomized controlled trial of Nissen versus anterior 180-degree partial fundoplication.Summary Background DataNissen 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 versus anterior 180-degree partial fundoplication at up to 10 years follow-up showed good outcomes for both procedures.MethodsOne hundred seven participants were randomized to Nissen versus anterior 180-degree partial fundoplication. Fifteen to 20 year follow-up data was available for 79 (41 Nissen, 38 anterior). Outcome was assessed using a standardized questionnaire with 0 to 10 analog scores and yes/no questions to determine reflux symptoms, side-effects, and satisfaction with surgery.ResultsAfter anterior fundoplication heartburn (mean score 3.2 vs 1.4, P = .001) and proton pump inhibitor use (41.7% vs 17.1%, P = .023) were higher, offset by less dysphagia for solids (mean score 1.8 vs 3.3, P = .015), and better ability to belch (84.2% vs 65.9%, P = .030). Measures of overall outcome were similar for both groups (mean satisfaction score 8.4 vs 8.0, P = .444; 86.8% vs 90.2% satisfied with outcome). Six participants underwent revision after anterior fundoplication (Nissen conversion for reflux - 6), and 7 underwent revision after Nissen fundoplication (Nissen to partial fundoplication for dysphagia - 5; redo Nissen for reflux - 1; paraesophageal hernia -1).ConclusionsAt 15 to 20 years follow-up Nissen and anterior 180-degree partial fundoplication achieved similar success, but with trade-offs between better reflux control versus more side-effects after Nissen fundoplication.Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.
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