Efficacy Of Hiatal Closure For GERD

Gastro Esophageal Reflux Clinical Trial

Official title:

Efficacy Of Hiatal Closure For GERD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06280664
• Other study ID #: IRB20-1151
• Status: Recruiting
• Start date: October 2, 2020
• Est. completion date: October 2024

Study information

• Verified date: February 2024
• Source: University of Chicago
• Contact: Yalini Vigneswaran, MD
• Phone: 773-702-6337
• Email: yvigneswaran[@]bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this protocol is to study the efficacy of hiatal closure for early GERD disease. The study team hypothesizes that hiatal closure for early GERD disease is an efficacious treatment of GERD.

Description:

Gastro-Esophageal Reflux Disease (GERD) affects 60 million Americans involving an estimated 20 million Americans dependent on long term medication to control symptoms and progression of the disease. Although surgical hiatal hernia repair and creation of an anti-reflux valve can correct the underlying cause of GERD by repairing the anatomic defect and reestablishing the competency of the lower esophageal sphincter (LES), only 24,000 patients annually undergo surgery for GERD. However, with the advent of minimally invasive laparoscopic techniques to treat GERD, more patients at early phases of the disorder are being surgically treated.

The traditional approach to surgical treatment of GERD has been hiatal hernia repair with Nissen fundoplication. However, fundoplication itself may be unnecessary for recovery of the lower esophageal sphincter. Several groups have demonstrated that partial or even minimal wrapping of the esophagus achieves equal control of GERD to complete wrapping. Despite extensive geometric and physics-based explanations for this observational enigma, the science underlying these highly reproducible observations across surgeons and continents remains poorly understood. Furthermore, outcomes following hiatal hernia repair alone for the treatment of GERD have not been studied since before the advances in laparoscopic technique.

Because of the high-volume gastrointestinal surgery center, the study team has the opportunity to rigorously study patient-centered outcomes and the disease processes as they are treated with this surgery. These outcomes after hiatal closure alone have not been published with the use of minimally invasive techniques where rigorous repairs can be achieved and thus, the study team is seeking this opportunity to demonstrate the efficacy of hiatal closure alone and recovery of the lower esophageal sphincter in those patients with symptomatic GERD and small hiatal defects. Publishing outcomes of this technique would represent a great leap forward in enhancing the knowledge base upon which to define the principles and techniques for the surgical treatment of GERD.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Age 18 - 50 years

• Able to provide informed consent

• BMI <30

• Hiatal defect <4cm on esophagram

• pH testing requirement: pH <4 for >5.5%

• Surgical candidate for hiatal closure only

Exclusion Criteria:

• Vulnerable subjects (children, prisoners, pregnant women) will be excluded.

Related Conditions & MeSH terms

• Gastro Esophageal Reflux
• Gastroesophageal Reflux

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of pH testing	Determine GERD remission for hiatal closure alone for patients with pH proven GERD	at 1 and 2 years