Condition category
Digestive System
Date applied
01/09/2005
Date assigned
01/09/2005
Last edited
12/11/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 investigatorÂ’s 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

Publication citations

Additional files

Editorial Notes