A Randomized Controlled Trial of Laparoscopic Nissen Fundoplication Treatment of Patients With Chronic GERD

November 14, 2012 updated by: Mehran Anvari, McMaster University

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

216

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Healthcare Hamilton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female GERD patients aged 18-70 years with GERD symptoms.
  • Prior long-term treatment with PPI with minimum duration of 1 year with expected future duration of at least 2 more years.
  • Controlled on 20-40mg/day maintenance PPI therapy prior to study, defined as GERD symptom score<18 and score of 70 or more on 1-100 Global Rating Scale at screening (on medication).
  • Increase in GERD symptom score>=15 points at baseline (off omeprazole).
  • GERD symptom score>=18 at baseline (off omeprazole).
  • Percent acid reflux in 24hr 4% at baseline (off omeprazole).
  • Positive Bernstein test at baseline.
  • Willingness to adhere to randomized treatment with availability for 3 years of follow-up.
  • Ability to answer self and interviewer-administered questions in English.
  • Signed informed consent.

Exclusion Criteria:

  • Aperistaltic esophagus.
  • Severe cardiac, respiratory, hematologic or other disease constituting an unacceptable surgical risk in the investigator's opinion.
  • Previous gastric, esophageal or anti-reflux surgery.
  • History of malignancy within the last year with the exception of basal cell carcinoma.
  • Pregnancy or an intention to become pregnant in the following year.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
GERD Symptom Scale
Symptom-free Day Measurement
Cost Measurement

Secondary Outcome Measures

Outcome Measure
Esophageal manometry
24-hour pH
Economic Analysis
Endoscopy
Health related quality of life (SF-36)
Health Utility Index
Respiratory function, airways hypersensitivity and inflammation and microaspiration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

St. Joseph's Healthcare Hamilton

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

November 15, 2012

Last Update Submitted That Met QC Criteria

November 14, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIHR-MCT-38147
  • MOH Grant 05276

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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