The purpose of this prospective observational research study registry is to examine whether two GERD surgeries (Laparoscopic Nissen Fundoplication (LNF) or Transoral Incisionless Fundoplication (TIF)) have similar outcomes in effectiveness, safety, post-operative side effects and post-procedure costs associated with episodes of care and any ensuing complications.
This registry will prospectively enroll 500 patients undergoing TIF and LNF from approximately 20 United States centers proficient in these procedures that have provided informed consent for the above mentioned data collection (symptom questionnaires, medical treatments, complications, side-effects and costs). The observational registry will obtain the patients clinical data related to gastrointestinal symptoms for three years post-consent. At baseline and for a three-year period following a clinically indicated TIF or LNF procedure, data will be obtained from phone calls and/or during office-visits made at specified intervals. During these data collection periods, patients will be asked to complete standard validated symptom questionnaires as well as report on episodes of care related to their procedures along with financial costs of care.
Study Type
OBSERVATIONAL
Enrollment
46
OC Reflux
Huntington Beach, California, United States
SurgOne Foregut Institute
Englewood, Colorado, United States
GI Solutions Inc
Chicago, Illinois, United States
Effectiveness as measured by a 75% reduction in GERD HRQL)
To compare the effectiveness of TIF and LNF at the end of three years compared to baseline using a 75% reduction in GERD Health-related Quality of Life (GERD-HRQL) as a threshold for effectiveness.
Time frame: 3 years
Effectiveness using a 50% reduction in GERD-HRQL
Compare effectiveness using a 50% reduction in GERD-HRQL as a threshold for effectiveness of TIF and LNF at the end of three years compared to baseline.
Time frame: 3 years
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NorthShore University HealthSystem
Evanston, Illinois, United States
Lenox Hill Hospital
New York, New York, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Texas at Houston
Bellaire, Texas, United States
Texas Tech University Health Sciences Center
El Paso, Texas, United States
Reston Hospital Center/ GW University
Reston, Virginia, United States