A Randomized Controlled Trial of Laparoscopic Nissen Fundoplication Treatment of Patients With Chronic GERD
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux
Study type: Interventional

Summary: 
      LNF is an effective intervention in the management of patients with chronic GERD requiring
      maintenance therapy. LNF is cost-effective compared with long-term medical therapy.

      LNF is more effective than maximum medical therapy in control of respiratory symptoms and
      complications of GERD.
    

Detailed description: 
      GERD encompasses a variety of symptoms and pathological findings caused by the reflux of
      gastric contents into the esophagus although symptoms and pathology may occur independently
      of each other. GERD usually presents with typical symptoms of retrosternal burning
      (heartburn) with or without chest pain and regurgitation of gastric contents into the back of
      the mouth. However, symptoms often occur in the absence of abnormalities associated with
      GERD, such as esophageal erosions, ulceration, stricturing or Barrett's esophagus. There is
      no clear correlation between symptoms and the histological features of GERD. Less prevalent
      manifestations of GERD include the geneses of dental erosions and respiratory disease
      including aspiration pneumonia, asthma, chronic laryngitis. Most often, GERD is due to
      excessive reflux of gastric contents into the esophagus rather than gastric acid
      hypersecretion. Reflux is caused by an increase in the frequency of inappropriate transient
      relaxations of the lower esophageal sphincter (LES). In most patients, basal resting LES
      pressure is normal although LES hypotonia, reduced esophageal body contractility and the
      presence of a hiatus hernia may exacerbate reflux or reduce esophageal clearance. Impaired
      esophageal mucosal resistance can increase the potential for esophageal damage. Bile acids
      and pancreatic enzymes have been implicated in the pathogenesis of GERD but it is generally
      accepted that the major causes of esophageal symptoms and injury are gastric acid and pepsin,
      which are active only at low ambient pH. Severity of esophagitis and of reflux symptoms
      correlate well with the duration of esophageal acid exposure with clear correlation between
      acid secretory inhibition and esophagitis healing rates for any given drug. On this basis,
      treatment for GERD has been directed towards:

      Minimization of potential precipitating factors by lifestyle modifications such as weight
      loss, small meals and, avoidance of alcohol and tobacco.

      Improving LES pressure, esophageal clearance and gastric emptying, using prokinetic agents.

      Neutralization of acid in the stomach or esophagus, using antacids. Reduction of acid
      secretion, using histamine receptor antagonists(H2RAs) or PPI's.

      Surgical prevention of gastro-esophageal reflux by fundoplication. In practice, the latter
      two approaches are the most successful for patients with more severe GERD and PPI's have
      proven more efficacious than H2RAs.
    

Intervention name(s): Proton Pump Inhibitors; Laparoscopic Nissen Fundoplication
Intervention type(s): Drug; Procedure
Intervention MeSH terms: Proton Pump Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment