Division of Gastroenterology, Hepatology and Nutrition Reflux Profiles As Predictors Of Post-fundoplication Outcome

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Principal Investigator: Rachel Rosen, MD, MPH

Department: Gastroenterology

Trial Description: The purpose of this study is to determine if certain clinic factors can predict patient outcome after fundoplication (reflux surgery). This study will explore if the amount of reflux and symptoms can predict which patients improve after reflux surgery. Many patients do well after surgery and their symptoms improve, however, some patients do not improve. Consequently, we are interested in finding better ways to predict who will improve after surgery. This study is collecting information before and after reflux surgery to find out how well a patient will do. In the future we hope to use this information to help patients improve their decision-making regarding reflux surgery.

Recruitment Info: Children between the ages of 6 months and 21 years undergoing a pH-impedance study for the evaluation of their reflux are eligible for this study, provided they have not had prior gastric or esophageal surgery. This study involves a 24-hour time commitment (the same as a regular pH-impedance study). A catheter that records pH, impedance, and manometry (pressures in the esophagus) is placed, and collects information for 20 hours. Participants complete two short questionnaires before the placement of the catheter. If the participant requires reflux surgery in the future they will be contacted by telephone 3 and 6 months after the procedure. There is no compensation for participation in this study.

Recruitment Contact: Katharine Rooney

Recruitment Contact Phone: 617-355-5998

Recruitment Contact Email: Katharine.Rooney@childrens.harvard.edu

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