Contact information
Type
Scientific
Primary contact
Dr Mehran Anvari
ORCID ID
Contact details
McMaster University
St. Joseph's Hospital
Department of Surgery
50 Charlton Ave. East
Hamilton
Ontario
L8N 4A6
Canada
+1 905 522 2951
anvari@univmail.cis.mcmaster.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00182260
Protocol/serial number
CIHR-MCT-38147; MOH Grant 05276
Study information
Scientific title
Acronym
ELVIS (oEsophagitis - Laparoscopy Versus Inhibitors of Secretion)
Study hypothesis
1. Laparoscopic Nissen Fundoplication (LNF) is an effective intervention in the management of patients with chronic Gastro-oEsophageal Reflux Disease (GERD) requiring maintenance therapy
2. LNF is cost-effective compared with long-term medical therapy
3. LNF is more effective than maximum medical therapy in control of respiratory symptoms and complications of GERD
Ethics approval
Ethics approval received from Research Ethics Board of St Joseph's Hospital on the 30th March 2000.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Gastro-Oesophageal Reflux Disease (GERD)
Intervention
Optimal medical therapy compared with anti reflux surgery - Laparoscopic Nissen Fundoplication (LNF).
Intervention type
Drug
Phase
Not Specified
Drug names
Omeprazole
Primary outcome measures
GERD Symptom Scale and Symptom-free days
Secondary outcome measures
1. 24-hour pH
2. Economic analysis
3. Endoscopy
4. Oesophageal manometry
5. Health related quality of life (36-item Short Form health survey [SF-36])
6. Health Utility Index
Overall trial start date
01/01/2000
Overall trial end date
30/09/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male or female GERD patients aged 18 - 70 years with GERD symptoms
2. Prior long-term treatment with Proton Pump Inhibitors (PPI) with minimum duration of 1 year with expected future duration of at least 2 more years
3. Controlled on 20 - 40 mg/day maintenance PPI therapy prior to study, defined as GERD symptom score less than 25 and score of 70 or more on 1 - 100 Global Rating Scale at screening
4. Increase in GERD symptom score greater than or equal to 15 points at baseline (off omeprazole)
5. GERD symptom score greater than or equal to 25 at baseline (off omeprazole)
6. Percent acid reflux in 24 hour 24% at baseline off omeprazole
7. Positive Bernstein test at baseline
8. Willingness to adhere to randomised treatment with availability for 3 years of follow-up
9. Ability to answer self and interviewer-administered questions in English
10. Signed informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
216
Participant exclusion criteria
1. Aperistaltic oesophagus
2. Severe cardiac, respiratory, haematologic or other disease constituting an unacceptable surgical risk in the investigators opinion
3. Previous gastric, oesophageal or anti-reflux surgery
4. History of malignancy within the last year with the exception of basal cell carcinoma
5. Pregnancy or an intention to become pregnant in the following year
Recruitment start date
01/01/2000
Recruitment end date
30/09/2007
Locations
Countries of recruitment
Canada
Trial participating centre
McMaster University
Hamilton, Ontario
L8N 4A6
Canada
Sponsor information
Organisation
McMaster University (Canada)
Sponsor details
1200 Main Street West
Hamilton
Ontario
L8N 3Z5
Canada
+1 905 525 9140
hsresadm@mcmaster.ca
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-38147)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Ministry of Health and Long-Term Care (Canada) (Grant No.: 05276)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary