A Randomized Controlled Trial of Laparoscopic Nissen Fundoplication Treatment of Patients With Chronic GERD

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

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 than maximum medical therapy in control of respiratory symptoms and complications of GERD.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McMaster University
• Collaborator: St. Joseph's Healthcare Hamilton
• Treatments: Proton Pump Inhibitors

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.