A randomised controlled trial of Laparoscopic Nissen Fundoplication (LNF) versus omeprazole for treatment of patients with chronic Gastro-oEsophageal Reflux Disease (GERD)
| ISRCTN | ISRCTN71436929 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71436929 |
| ClinicalTrials.gov number | NCT00182260 |
| Secondary identifying numbers | CIHR-MCT-38147; MOH Grant 05276 |
- Submission date
- 01/09/2005
- Registration date
- 01/09/2005
- Last edited
- 31/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Mehran Anvari
Scientific
Scientific
McMaster University
St. Joseph's Hospital
Department of Surgery
50 Charlton Ave. East
Hamilton, Ontario
L8N 4A6
Canada
| Phone | +1 905 522 2951 |
|---|---|
| anvari@univmail.cis.mcmaster.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | A randomized controlled trial of laparoscopic Nissen fundoplication versus proton pump inhibitors for the treatment of patients with chronic gastroesophageal reflux disease (GERD): 3-year outcomes. |
| Study acronym | ELVIS (oEsophagitis - Laparoscopy Versus Inhibitors of Secretion) |
| Study objectives | 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(s) | Ethics approval received from Research Ethics Board of St Joseph's Hospital on the 30th March 2000. |
| Health condition(s) or problem(s) studied | Gastro-Oesophageal Reflux Disease (GERD) |
| Intervention | Optimal medical therapy compared with anti reflux surgery - Laparoscopic Nissen Fundoplication (LNF). |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Omeprazole |
| Primary outcome measure | 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 study start date | 01/01/2000 |
| Completion date | 30/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 216 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2000 |
| Date of final enrolment | 30/09/2007 |
Locations
Countries of recruitment
- Canada
Study participating centre
McMaster University
Hamilton, Ontario
L8N 4A6
Canada
L8N 4A6
Canada
Sponsor information
McMaster University (Canada)
University/education
University/education
1200 Main Street West
Hamilton, Ontario
L8N 3Z5
Canada
| Phone | +1 905 525 9140 |
|---|---|
| hsresadm@mcmaster.ca | |
"ROR" |
https://ror.org/02fa3aq29 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-38147)
No information available
Ministry of Health and Long-Term Care (Canada) (Grant No.: 05276)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | economic evaluation results | 01/03/2011 | 31/01/2019 | Yes | No |
| Results article | results | 01/08/2011 | 31/01/2019 | Yes | No |
Editorial Notes
31/01/2019: Publication reference added
