A Randomized Controlled Trial of Laparoscopic Nissen Fundoplication Treatment of Patients With Chronic GERD
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|ClinicalTrials.gov Identifier: NCT00182260|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : November 15, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Gastroesophageal Reflux||Drug: Proton Pump Inhibitors Procedure: Laparoscopic Nissen Fundoplication||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||216 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||ELVIS (Esophagitis-Laparoscopy Versus Inhibitors of Secretion) A Randomized Controlled Trial of Laparoscopic Nissen Fundoplication (LNF) Versus Omeprazole for Treatment of Patients With Chronic Gastro-Esophageal Reflux Disease (GERD)|
|Study Start Date :||January 2000|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
Active Comparator: Proton Pump Inhibitor
Patients randomized to medical therapy received optimized treatment with PPI using a standardized management protocol based on best evidence and published guidelines.
|Drug: Proton Pump Inhibitors|
Active Comparator: Laparoscopic Nissen Fundoplication
Surgical patients underwent LNF using previously published technique.
|Procedure: Laparoscopic Nissen Fundoplication|
- GERD Symptom Scale
- Symptom-free Day Measurement
- Cost Measurement
- 24-hour pH
- Economic Analysis
- Esophageal manometry
- Health related quality of life (SF-36)
- Health Utility Index
- Respiratory function, airways hypersensitivity and inflammation and microaspiration
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00182260
|St. Joseph's Healthcare Hamilton|
|Hamilton, Ontario, Canada, L8N 4A6|
|Principal Investigator:||Mehran Anvari, MB, BS, PhD||McMaster University|
|Principal Investigator:||David Armstrong, MB, BCh, MA||McMaster University|
|Principal Investigator:||Charles H. Goldsmith, PhD||McMaster University|