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A Randomized Controlled Trial of Laparoscopic Nissen Fundoplication Versus Proton Pump Inhibitors for Treatment of Patients With Chronic Gastroesophageal Reflux Disease: One-Year Follow-Up

Department of Surgery, St Joseph's Healthcare, 50 Charlton Ave E, Hamilton, ON, L8N 4A6 Canada; anvari{at}mcmaster.ca

Christopher Allen, BM, BCh

John Marshall, MD, MSc

David Armstrong, MA, MB, BCh

Departments of Medicine St Joseph's Healthcare, Hamilton–McMaster University, Hamilton

Ron Goeree, MA

Clinical Epidemiology & Biostatistics St Joseph's Healthcare, Hamilton–McMaster University, Hamilton

Wendy Ungar, PhD

Hospital for Sick Children, University of Toronto, Ontario, Canada

Charles Goldsmith, PhD

Clinical Epidemiology & Biostatistics St Joseph's Healthcare, Hamilton–McMaster University, Hamilton

A randomized controlled trial conducted in patients with gastroesophageal reflux disease compared optimized medical therapy using proton pump inhibitor (n = 52) with laparoscopic Nissen fundoplication (n = 52). Patients were monitored for 1 year. The primary end point was frequency of gastroesophageal reflux dis-ease symptoms. Surgical patients had improved symptoms, pH control, and overall quality of life health index after surgery at 1 year compared with the medical group. The overall gastroesophageal reflux disease symptom score at 1 year was unchanged in the medical patients, but improved in the surgical patients. Fourteen patients in the medical arm experienced symptom relapse requiring titration of the proton pump inhibitor dose, but 6 had satisfactory symptom remission. No surgical patients required additional treatment for symptom control. Patients controlled on long-term proton pump inhibitor therapy for chronic gastroesophageal reflux disease are excellent surgical candidates and should experience improved symptom control after surgery at 1 year.

Key Words: gastroesophageal reflux disease • laparoscopic Nissen fundoplication • proton pump inhibitors

Surgical Innovation, Vol. 13, No. 4, 238-249 (2006)
DOI: 10.1177/1553350606296389


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