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

Gastro Esophageal Reflux Clinical Trial

— GERD  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03143608
• Other study ID #: 04/03/2014
• Status: Completed
• Phase: N/A
• First received: April 29, 2017
• Last updated: May 5, 2017
• Start date: May 1, 2014
• Est. completion date: December 31, 2016

Study information

• Verified date: May 2017
• Source: Mavrelis, Peter G., M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastro Esophageal Reflux
• Gastroesophageal Reflux
• Hernia
• Hernia, Hiatal

Intervention

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

Locations

Country	Name	City	State
United States	Affinity Health System	Appleton	Wisconsin
United States	Methodist Hospital	Merrillville	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Peter G Mavrelis

Country where clinical trial is conducted

United States, 

References & Publications (1)

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; discussio — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Control of GERD symptoms	GERD health related quality of life questionnaire	one year
Primary	Control of GERD symptoms	Reflux symptom index questionnaire	one year
Primary	Control of GERD symptoms	Gastrointestinal symptom rating scale	one year