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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

99 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-01

Study Completion Date

2016-12-31

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.

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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

Conditions

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Gastro Esophageal Reflux

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Indiana group

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

Esophyx

Intervention Type DEVICE

Laparoscopic hiatal hernia repair followed immediately by transoral incisionless fundoplication under general anesthesia using the Esophyx device

Wisconsin group

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

Esophyx

Intervention Type DEVICE

Laparoscopic hiatal hernia repair followed immediately by transoral incisionless fundoplication under general anesthesia using the Esophyx device

Interventions

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Esophyx

Laparoscopic hiatal hernia repair followed immediately by transoral incisionless fundoplication under general anesthesia using the Esophyx device

Intervention Type DEVICE

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.