NCT02211105

Registry to Compare Two Surgical Treatments for GERD

Laparoscopic Nissen Fundoplication (LNF) Surgery Versus Transoral Incisionless Fundoplication (TIF): Anti- Reflux Treatment Registry

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 46 (actual)
• Sponsor: American Gastroenterological Association · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• GastroEsophageal Reflux Disease

Timeline

• Start date: 2014-07-01
• Primary completion: 2017-04-01
• Completion: 2017-04-01
• First posted: 2014-08-07
• Last updated: 2018-01-09

Locations

10 sites across 1 country: United States