Gastroesophageal reflux disease (GERD) is one of the most common disorders of the gastrointestinal tract. Approximately 75 million Americans suffer from """"""""heartburn"""""""", the most typical symptom of GERD. Heartburn can severely impact quality of life and leads to an estimated 15 million physician consultations per year. Both medical and surgical treatments have been shown to be effective in controlling symptoms of GERD, but surgical intervention has traditionally been reserved for selected patients with intractable symptoms. However, for both medical and surgical treatment of GERD, the landscape has changed significantly in the last decade. Proton pump inhibitor therapy has proven vastly superior to older anti- acid medications. Concurrently, the advent of minimally invasive laparoscopic surgery as substantially lowered the threshold for surgical treatment of GERD and led to substantial increases in rates of anti-reflux surgery. Both of these advances have sharpened the debate surrounding optimal treatment of GERD, but at present there is insufficient evidence on which to base comparispon of medical and surgical treatment. A careful, prospective, multi-enter, randomized clinical trial would be the ideal mechanism for comparing proton pump inhibitor therapy and laparoscopic anti-reflux surgery for GERD. The purpose of this application is to seek funds to design and plan such a trial. As members of an experienced clinical trial consortium, we recognize that conducing this trial will require successfully overcoming several important challenges, including issues of patient recruitment and retention, generalizability, and measurement of quality-of-life outcomes. The R03 grant would provide the required financial resources to carefully address these challenges.
