Clinical trial NCT06280664: Efficacy Of Hiatal Closure For GERD
Official title: Efficacy Of Hiatal Closure For GERD
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastro Esophageal Reflux
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Concentration of pH testing
timeFrame: at 1 and 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Yalini Vigneswaran, MD
role: PRINCIPAL_INVESTIGATOR
References: