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

Completed

• Conditions: Gastro Esophageal Reflux
• Interventions: Device: Esophyx

• Registration Number: NCT03143608
• Lead Sponsor: Peter G Mavrelis

Brief Summary

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

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

Study Timeline

• Study Start: 2014-05-01
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Study First Submitted: 2017-04-29
• Status Verified: 2017-05
• Study First Submitted QC: 2017-05-05
• Last Update Submitted: 2017-05-05
• Study First Posted: 2017-05-08
• Last Update Posted: 2017-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Indiana group	Esophyx	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
Wisconsin group	Esophyx	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

Primary Outcome Measures

Name	Time	Method
Control of GERD symptoms	one year	Gastrointestinal symptom rating scale

Trial Locations

Locations (2)

Affinity Health System; 🇺🇸 Appleton, Wisconsin, United States

Methodist Hospital; 🇺🇸 Merrillville, Indiana, United States