GERD Treatment With Transoral Incisionless Fundoplication (TIF) Following Hiatal Hernia Surgery

Study Overview
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Brief Summary
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The investigators prospectively studied ninety nine GERD patients following laparoscopic hiatal surgery combined with transoral incisionless fundoplication at two community hospitals. General surgeons and gastroenterologists participated in the study. GERD questions were recorded before and at six and twelve months.

Detailed Description
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GERD unresponsive to medical therapies can be treated by laparoscopic Nissen fundoplication or endoluminal techniques. The investigators have extensive experience with Transoral Incisionless Fundoplication(TIF). TIF is not indicated in patients with a hiatal hernia larger than 2 cm. Performing a Hiatal Hernia Repair(HHR) in those cases will make a patient eligible for TIF. HHR followed immediately by the TIF procedure under the same anesthetic session is called a Hybrid-TIF (HTIF). The study examines the safety and efficacy of this approach. Prospective data were collected from patients who underwent HTIF at two 300 bed community hospitals. Questionnaires were administered before the procedure, and mailed at 6 and 12 mos. They were the GERD-HRQL-health related quality of life, RSI-reflux symptom index, and GSRS-gastrointestinal symptom rating scale. The study continues with the new Esophyx-Z device

Official Title
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Laparoscopic Hiatal Hernia Repair Followed Immediately By Transoral Incisionless Fundoplication Using the Esophyx Device: Efficacy And Safety In 99 Patients In A Community Setting

Conditions
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Gastro Esophageal Reflux

Intervention / Treatment
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* Device: Esophyx


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with typical or atypical GERD who want a surgical solution to control symptoms. Patients need a 2-5 cm hiatal hernia and have a BMI of less than 36. Exclusion Criteria: Hiatal hernias larger than 5 cm and BMI greater than 36.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Indiana group<br>50 adult patients males and females with GERD and 2-5 cm hiatal hernias. Each had laparoscopic hiatal hernia repair followed by transoral incisionless fundoplication | Device: Esophyx<br>* Laparoscopic hiatal hernia repair followed immediately by transoral incisionless fundoplication under general anesthesia using the Esophyx device<br>|
| Wisconsin group<br>49 adult patients males and females with GERD and 2-5 cm hiatal hernias. Each had laparoscopic hiatal hernia repair followed by transoral incisionless fundoplication | Device: Esophyx<br>* Laparoscopic hiatal hernia repair followed immediately by transoral incisionless fundoplication under general anesthesia using the Esophyx device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Control of GERD symptoms | GERD health related quality of life questionnaire | one year | 
| Control of GERD symptoms | Reflux symptom index questionnaire | one year | 
| Control of GERD symptoms | Gastrointestinal symptom rating scale | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GERD, Hiatal hernia repair, Transoral Incision less fundoplication