Status:
COMPLETED
A Randomized Controlled Trial of Laparoscopic Nissen Fundoplication Treatment of Patients With Chronic GERD
Lead Sponsor:
McMaster University
Collaborating Sponsors:
St. Joseph's Healthcare Hamilton
Conditions:
Gastroesophageal Reflux
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
LNF is an effective intervention in the management of patients with chronic GERD requiring maintenance therapy. LNF is cost-effective compared with long-term medical therapy. LNF is more effective th...
Detailed Description
GERD encompasses a variety of symptoms and pathological findings caused by the reflux of gastric contents into the esophagus although symptoms and pathology may occur independently of each other. GERD...
Eligibility Criteria
Inclusion
- Male and female GERD patients aged 18-70 years with GERD symptoms.
- Prior long-term treatment with PPI with minimum duration of 1 year with expected future duration of at least 2 more years.
- Controlled on 20-40mg/day maintenance PPI therapy prior to study, defined as GERD symptom score\<18 and score of 70 or more on 1-100 Global Rating Scale at screening (on medication).
- Increase in GERD symptom score\>=15 points at baseline (off omeprazole).
- GERD symptom score\>=18 at baseline (off omeprazole).
- Percent acid reflux in 24hr 4% at baseline (off omeprazole).
- Positive Bernstein test at baseline.
- Willingness to adhere to randomized treatment with availability for 3 years of follow-up.
- Ability to answer self and interviewer-administered questions in English.
- Signed informed consent.
Exclusion
- Aperistaltic esophagus.
- Severe cardiac, respiratory, hematologic or other disease constituting an unacceptable surgical risk in the investigator's opinion.
- Previous gastric, esophageal or anti-reflux surgery.
- History of malignancy within the last year with the exception of basal cell carcinoma.
- Pregnancy or an intention to become pregnant in the following year.
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT00182260
Start Date
January 1 2000
End Date
April 1 2010
Last Update
November 15 2012
Active Locations (1)
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1
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6