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Registry to Compare Two Surgical Treatments for GERD — STAR Registry  

GastroEsophageal Reflux Disease Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02211105
Study type Observational [Patient Registry]
Source American Gastroenterological Association
Contact
Status Terminated
Phase N/A
Start date July 2014
Completion date April 2017
View Details
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