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

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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN71436929

Enrollment

216

Registered

2005-09-01

Start date

2000-01-01

Completion date

Unknown

Last updated

2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastro-Oesophageal Reflux Disease (GERD) Digestive System Gastro-Oesophageal Reflux Disease (GERD)

Interventions

Optimal medical therapy compared with anti reflux surgery - Laparoscopic Nissen Fundoplication (LNF).

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
GERD Symptom Scale and Symptom-free days	—

Secondary

Measure	Time frame
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	—

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026