Focus of Report: The focus of this Health Technology Assessment is to evaluate the effectiveness and safety of transoral incisionless fundoplication (TIF) 2.0 when performed concomitantly with laparoscopic hiatal hernia repair (concomitant transoral incisionless fundoplication [cTIF]) for the treatment of chronic gastroesophageal reflux disease (GERD) in adults.
Technology Description: TIF 2.0 alone has traditionally not been cleared when a hiatal hernia > 2 centimeters (cm) is present. TIF 2.0 following laparoscopic hiatal hernia repair for patients with these larger hernias is evaluated in this report.
Controversy: Laparoscopic fundoplication is effective for the treatment of GERD and hiatal hernia repair and is less invasive than open fundoplication. However, it still leaves a scar and carries the possibility of upper gastrointestinal complications. TIF 2.0 has been available since 2009 and is one of several minimally invasive treatments for GERD that is not fully responsive to medication. TIF 2.0 concomitant with laparoscopic hiatal hernia repair (cTIF) has only been indicated since 2017, and its long-term effectiveness and its long-term effectiveness compared with alternative treatments is unclear.
Key Questions:
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Is cTIF effective for the treatment of GERD in adults?
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How does cTIF compare with other treatments for GERD in adults with clinically significant hiatal hernia?
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Is cTIF in patients with GERD and clinically significant hiatal hernia safe?
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Have definitive patient selection criteria been identified for cTIF for treatment of GERD in adults with clinically significant hiatal hernia?
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