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 (NCT)	NCT00182260
Protocol serial number	CIHR-MCT-38147; MOH Grant 05276
Sponsor	McMaster University (Canada)
Funders	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-38147), Ministry of Health and Long-Term Care (Canada) (Grant No.: 05276)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Mehran Anvari
Scientific

McMaster University
St. Joseph's Hospital
Department of Surgery
50 Charlton Ave. East
Hamilton, Ontario
L8N 4A6
Canada

Phone	+1 905 522 2951
Email	anvari@univmail.cis.mcmaster.ca

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Omeprazole
Primary outcome measure(s)	GERD Symptom Scale and Symptom-free days
Key secondary outcome measure(s)	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
Completion date	30/09/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

McMaster University

Hamilton, Ontario
L8N 4A6
Canada

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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

31/01/2019: Publication reference added