Efficacy Of Hiatal Closure For GERD

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.

Study Overview

• Status: Recruiting
• Conditions: Gastro Esophageal Reflux

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Yalini Vigneswaran, MD; Phone Number: 773-702-6337; Email: yvigneswaran@bsd.uchicago.edu
• Study Contact Backup: Name: John Alverdy, MD; Email: jalverdy@bsd.uchicago.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • The University of Chicago
      • Contact: Carlisa Dixon; Phone Number: 773-834-4337; Email: cdixon520@bsd.uchicago.edu
      • Contact: Leila Yazdanbakhsh; Phone Number: 773-834-5087; Email: leila.yazdanbakhsh@bsd.uchicago.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The estimated annual number of subjects enrolled prospectively in the study is 20. The recruitment goal is 40. The research team will screen all patients that are being followed-up at the gastrointestinal surgery clinic at the UCM.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of pH testing	Determine GERD remission for hiatal closure alone for patients with pH proven GERD	at 1 and 2 years

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Yalini Vigneswaran, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2020
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: February 19, 2024
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Estimated): February 28, 2024

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux
• Other Study ID Numbers: IRB20-1151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No