Skip to main content
OpenTrials
Completed

NCT Number: NCT03143608

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastro Esophageal Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Methodist Hospital, Merrillville, Indiana, United States

Loading trial locations.

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Esophyx

Device

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

Primary outcomes

  1. Control of GERD symptoms

    Time frame: one year

    GERD health related quality of life questionnaire

  2. Control of GERD symptoms

    Time frame: one year

    Reflux symptom index questionnaire

  3. Control of GERD symptoms

    Time frame: one year

    Gastrointestinal symptom rating scale

Sponsors and collaborators

Lead sponsor

Peter G Mavrelis

Indiv

Registry information

Official study title

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

Acronym: GERD

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 8, 2017
Registry last updated
May 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.