A randomised controlled trial of Laparoscopic Nissen Fundoplication (LNF) versus omeprazole for treatment of patients with chronic Gastro-oEsophageal Reflux Disease (GERD)

Not Applicable

Completed

• Conditions: Gastro-Oesophageal Reflux Disease (GERD); Digestive System

• Registration Number: ISRCTN71436929
• Lead Sponsor: McMaster University (Canada)

Brief Summary

1. 2011 results in https://www.ncbi.nlm.nih.gov/pubmed/21512887 (added 31/01/2019) 2. 2011 economic evaluation results in https://www.ncbi.nlm.nih.gov/pubmed/21402295 (added 31/01/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-01
• Study Completion: 2007-09-30
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 216

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

Exclusion Criteria

1. Aperistaltic oesophagus
2. Severe cardiac, respiratory, haematologic or other disease constituting an unacceptable surgical risk in the investigator?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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
GERD Symptom Scale and Symptom-free days

Secondary Outcome Measures

Name	Time	Method
<br> 1. 24-hour pH<br> 2. Economic analysis<br> 3. Endoscopy<br> 4. Oesophageal manometry<br> 5. Health related quality of life (36-item Short Form health survey [SF-36])<br> 6. Health Utility Index<br>