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NCT Number: NCT06280664

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.

Recruiting

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. Concentration of pH testing

    Time frame: at 1 and 2 years

    Determine GERD remission for hiatal closure alone for patients with pH proven GERD

Study contacts

Contact information is provided by the study sponsor or research team.

John Alverdy, MD

CONTACT

[email protected]

Yalini Vigneswaran, MD

CONTACT

[email protected]

773-702-6337

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Important dates

Study start
2020
Primary completion
2028
Study completion
2028
First posted
Feb 28, 2024
Registry last updated
Feb 2, 2026

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.

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