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

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

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.

Study Overview

• Status: Completed
• Conditions: Gastro Esophageal Reflux
• Intervention / Treatment: Device: Esophyx

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 Type: Observational
• Enrollment (Actual): 99

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Merrillville, Indiana, United States, 46410
      • Methodist Hospital
  • Wisconsin
    • Appleton, Wisconsin, United States, 54915
      • Affinity Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults with GERD

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Device: Esophyx; 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	Device: Esophyx; Laparoscopic hiatal hernia repair followed immediately by transoral incisionless fundoplication under general anesthesia using the Esophyx device

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peter G Mavrelis
• Investigators: Principal Investigator: Peter Mavrelis, MD, The Methodist Hospital Research Institute

Publications and helpful links

General Publications

• Ihde GM, Besancon K, Deljkich E. Short-term safety and symptomatic outcomes of transoral incisionless fundoplication with or without hiatal hernia repair in patients with chronic gastroesophageal reflux disease. Am J Surg. 2011 Dec;202(6):740-6; discussion 746-7. doi: 10.1016/j.amjsurg.2011.06.035. Epub 2011 Oct 20.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: April 29, 2017
• First Submitted That Met QC Criteria: May 5, 2017
• First Posted (Actual): May 8, 2017

Study Record Updates

• Last Update Posted (Actual): May 8, 2017
• Last Update Submitted That Met QC Criteria: May 5, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: GERD; Hiatal hernia repair; Transoral Incision less fundoplication
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pathological Conditions, Anatomical; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Hernia, Diaphragmatic; Internal Hernia; Hernia; Gastroesophageal Reflux; Hernia, Hiatal
• Other Study ID Numbers: 04/03/2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: presentation at national meeting

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes