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The TEMPO Trial at 5 Years: Transoral Fundoplication (TIF 2.0) Is Safe, Durable, and Cost-effective

Trad KS, Fox MA, Simoni G, Shughoury AB, Mavrelis PG, Raza R, Heise JA, Barnes WE
Surgical Innovation (2018) https://doi.org/10.1177/1553350618755214 [epub ahead of print]

TEMPO 5Y TIF 2.0 ProcedureBackground. 

Questions remain about the therapeutic durability of transoral incisionless fundoplication (TIF). In this study, clinical outcomes were evaluated at 5 years post-TIF 2.0.

Methods.

A total of 63 chronic gastroesophageal reflux disease (GERD) sufferers with troublesome symptoms refractory to proton pump inhibitor (PPI) therapy, absent or ≤2 cm hiatal hernia, and abnormal esophageal acid exposure were randomized to the TIF group or PPI group. Following the 6-month evaluation, all patients in the PPI group elected for crossover to TIF; therefore, all 63 patients underwent TIF 2.0 with EsophyX2 device. Primary outcome was elimination of daily troublesome regurgitation and atypical symptoms at the 5-year follow-up. Secondary outcomes were improvement in symptom scores, PPI use, reoperations, and patient health satisfaction. The cost-effectiveness of TIF 2.0 was also estimated.

Results.

Of 63 patients, 60 were available at 1 year, 52 at 3 years, and 44 at 5 years for evaluation. Troublesome regurgitation was eliminated in 88% of patients at 1 year, 90% at 3 years, and 86% at 5 years. Resolution of troublesome atypical symptoms was achieved in 82% of patients at 1 year, 88% at 3 years, and 80% at 5 years. No serious adverse events occurred. There were 3 reoperations by the end of the 5-year follow-up. At the 5-year follow-up, 34% of patients were on daily PPI therapy as compared with 100% of patients at screening. The total GERD Health-related quality-of-life score improved by decreasing from 22.2 to 6.8 at 5 years (P < .001).

Conclusion.

In this patient population, the TIF 2.0 procedure provided safe and sustained long-term elimination of troublesome GERD symptoms.

Link to open access article: Trad KS, et al. Surg Innov 2018 Feb 6. [Epub ahead of print]

PDF Download of TEMPO 5Y data slides

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About GERD

  • What Is GERD (Gastroesophageal Reflux Disease)?
  • GERD Symptoms: Signs of Acid Reflux Disease
  • What Causes Gastroesophageal Reflux Disease (GERD)?
  • Hiatal Hernia and the TIF procedure
  • Diagnosis of GERD: How Gastroesophageal Reflux Disease is Diagnosed

Treatments

  • Treatment Options for GERD
  • Treating GERD with Diet and Lifestyle Changes
  • Medications for GERD Treatment
  • Antireflux Surgery: Types of Fundoplication

Tif Procedure

  • TIF Procedure: Transoral Incisionless Fundoplication Surgery
  • Comparison of the TIF Procedure and Nissen Fundoplication
  • Is the TIF Procedure Right for You?
  • What to Expect Before, During, and After TIF Procedure
  • Clinical Results for the TIF Procedure
  • TIF Procedure Side Effects, Risks, and Complications: Safety Information For Potential Patients
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  • Frequently Asked Questions

Resources

  • Patient Resources
  • Patient Stories
  • Frequently Asked Questions: TIF Surgery and the EsophyX Device to Treat GERD
  • GERD-HRQL: Health Related Quality of Life Questionnaire
  • Questions for your Doctor: What to Ask About GERD Diagnosis and Treatment
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This site is published by EndoGastric Solutions, Inc., and is intended as an information resource to help increase awareness of GERD-related disorders and the available treatment options. This site is not a substitute for medical advice from your physician. The contents of the site are for informational purposes only and are intended to be discussed with your physician. Never disregard any advice given to you by your physician or other qualified healthcare professional. Always seek the advice of a physician or other licensed healthcare professional regarding any questions you have about your medical conditions and treatments.

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  • What is GERD
    • Overview
    • GERD Symptoms: Signs of Acid Reflux Disease
    • What Causes Gastroesophageal Reflux Disease (GERD)?
    • Hiatal Hernia and the TIF procedure
    • Diagnosis of GERD: How Gastroesophageal Reflux Disease is Diagnosed
  • GERD Treatment Options
    • Overview
    • Treating GERD with Diet and Lifestyle Changes
    • Medications for GERD Treatment
    • Antireflux Surgery: Types of Fundoplication
  • TIF Procedure: Transoral Incisionless Fundoplication Surgery
    • Overview
    • Comparison of the TIF Procedure and Nissen Fundoplication
    • Is the TIF Procedure Right for You?
    • What to Expect Before, During, and After TIF Procedure
    • Clinical Results for the TIF Procedure
    • TIF Procedure Side Effects, Risks, and Complications: Safety Information For Potential Patients
    • Affording the TIF Procedure: Costs and Insurance Coverage
    • Frequently Asked Questions: TIF Surgery and the EsophyX Device to Treat GERD
  • Patient Resources
    • Patient Stories
    • Frequently Asked Questions: TIF Surgery and the EsophyX Device to Treat GERD
    • GERD-HRQL: Health Related Quality of Life Questionnaire
    • Questions for your Doctor: What to Ask About GERD Diagnosis and Treatment
    • Additional Reflux and GERD Resources
    • Glossary of Terminology
  • Blog
  • News
    • Media Coverage
    • Press Releases
  • Contact Us
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