A Randomized Controlled Trial of Laparoscopic Nissen Fundoplication (LNF) versus Proton Pump Inhibitors for Treatment of Patients with Chronic Gastro-Esophageal Reflux Disease (GERD)

Objective: In patients with GERD who were stable and symptomatically controlled on long-term medical therapy we performed an RCT to compare ongoing optimized medical therapy with LNF.
Methods: 201 patients were eligible for randomization, 104 gave informed consent (age mean 42.9, sd11; male 55 female 49) and 2 withdrew from the study immediately after randomization. Patients randomized to medical therapy received optimized treatment with PPI using a standardized management protocol based on best evidence and published guidelines. Surgical patients underwent LNF by four surgeons using previously published technique. Patients underwent symptom evaluation using the GERD symptom score (GSS), a published and validated instrument and the Global Rating Scale (GRS) for overall symptom control. Patients had 24 hour pH testing at baseline and after 3 years. Medical patients were evaluated on PPI, surgical patients off PPI.
Results: 94 patients were available for 3 year follow up. Both groups improved significantly with regard to pH (medical p=0.0200, surgical p=0.0246) and GSS (both groups p

Session: Podium Presentation

Program Number: S081