W1853 Ten-Year Outcome of Laparoscopic and Conventional Nissen Fundoplication: Randomized Clinical Trial

Department of Surgery, Gastrointestinal Research Center of the University Medical Center Utrecht, Utrecht 3508 GA, The Netherlands.
Annals of surgery (Impact Factor: 8.33). 10/2009; 250(5):698-706. DOI: 10.1097/SLA.0b013e3181bcdaa7
Source: PubMed


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.
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.
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.
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.
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.

  • [Show abstract] [Hide abstract]
    ABSTRACT: The numerical simulation of high power ultrasonic devices is a highly challenging task, since a multi-field problem based on nonlinear partial differential equations has to be solved. We will concentrate on the numerical simulation of piezoelectric and electromagnetic pulsed acoustic power sources as well as on a piezoelectric driven cw-source. Our calculation scheme is based on the Finite Element Method. It is capable to handle both the transducer and acoustic nonlinearities. Practical applications will demonstrate the applicability of our simulation scheme.
    Ultrasonics Symposium, 2002. Proceedings. 2002 IEEE; 11/2002
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: The Rome III criteria classify patients with a positive relationship between symptoms and reflux episodes but a physiological oesophageal acid exposure time as having gastro-oesophageal reflux disease (GORD) with an acid hypersensitive oesophagus. The long-term outcome of antireflux surgery in these patients was investigated. Outcomes of Nissen fundoplication in 28 patients with GORD refractory to proton-pump inhibitors (PPIs) and oesophageal acid hypersensitivity (group 1) were compared with those of 126 patients with pathological acid exposure (group 2). Fundoplication had a similar effect in both groups. Three months after surgery, total acid exposure time and the prevalence of oesophagitis had decreased, whereas mean lower oesophageal pressure had increased. The percentage of patients using PPIs was reduced from 83 to 4 per cent in group 1 and from 86.1 to 7.4 per cent in group 2 (both P < 0.001). Quality of life measured on a scale from 0 to 100 improved from 52 to 69 (P = 0.009) and 64 (P < 0.001) respectively. The percentage of patients with resolved or improved symptoms at 5 years was similar. Patients with oesophageal acid hypersensitivity benefit from Nissen fundoplication as much as those with pathological acid exposure.
    British Journal of Surgery 09/2009; 96(9):1023-30. DOI:10.1002/bjs.6684 · 5.54 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: uy frecuente. Tiene morbilidad significativa y representa uno de los diagnósticos más comunes en la consulta externa. Un estudio transversal llevado a cabo en población mexicana calcula que 25% de los adultos sufre síntomas relacionados con ERGE. Los objetivos terapéuticos en esta enfermedad son la eliminación de los síntomas, la reversión de algunas de las complicaciones adjuntas y la prevención de la recurrencia sintomática o las complicaciones. Las opciones de tratamiento incluyen la terapia médica y la quirúrgica, mientras que la terapéutica endoscópica se halla en evaluación. Estas opciones pueden usarse solas o, en algunos casos, en combinación. Ninguna de estas modalidades es perfecta y la decisión sobre el tratamiento a elegir debe tomar en cuenta criterios de selección para procedimientos invasivos, la disponibilidad de éstos y las preferencias del paciente.
    Revista de gastroenterologia de Mexico 01/2010; 1(75):216-218.
Show more