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Randomized Controlled Trial Multicenter Study
Seventeen-year Outcome of a Randomized Clinical Trial Comparing Laparoscopic and Conventional Nissen Fundoplication: A Plea For Patient Counseling and Clarification.
- Jelmer E Oor, David J Roks, Joris A Broeders, Eric J Hazebroek, and Hein G Gooszen.
- *St. Antonius Hospital, Department of Surgery, Nieuwegein, The Netherlands †Radboud University Medical Center, Department of Operation Rooms/Evidence Based Surgery, Nijmegen, The Netherlands ‡University Medical Center Utrecht, Department of Surgery, Utrecht, The Netherlands.
- Ann. Surg. 2017 Jul 1; 266 (1): 23-28.
ObjectiveTo analyze long-term outcome of a randomized clinical trial comparing laparoscopic Nissen fundoplication (LNF) and conventional Nissen fundoplication (CNF) for the treatment of gastroesophageal reflux disease (GERD).BackgroundLNF has replaced CNF, based on positive short and mid-term outcome. Studies with a follow-up of over 15 years are scarce, but are desperately needed for patient counselling.MethodsBetween 1997 and 1999, 177 patients with proton pump inhibitor (PPI)-refractory GERD were randomized to CNF or LNF. Data regarding the presence of reflux symptoms, dysphagia, general health, PPI use, and need for surgical reintervention at 17 years are reported.ResultsA total of 111 patients (60 LNF, 51 CNF) were included. Seventeen years after LNF and CNF, 90% and 95% of the patients reported symptom relief, with no differences in GERD symptoms or dysphagia. Forty-three and 49% of the patients used PPIs (NS). Both groups demonstrated significant improvement in general health (77% vs 71%; NS) and quality of life (75.3 vs 74.7; NS). Surgical reinterventions were more frequent after CNF (18% vs 45%; P = 0.002), mainly due to incisional hernia corrections (3% vs 14%; P = 0.047).ConclusionsThe effects of LNF and CNF on symptomatic outcome and general state of health remain for up to 17 years after surgery, with no differences between the 2 procedures. CNF carries a higher risk of surgical reintervention, mainly due to incisional hernia corrections. Patients should be informed that 17 years after Nissen fundoplication, 60% of the patients are off PPIs, and 16% require reoperation for recurrent GERD and/or dysphagia.
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