Establishing a Correlation Between HRM and UGI MM Studies

Last updated: April 14, 2025
Sponsor: Lexington Health Incorporated
Overall Status: Terminated

Phase

N/A

Condition

Esophageal Disorders

Treatment

N/A

Clinical Study ID

NCT06314893
LMCII2022-001
  • Ages > 18
  • All Genders

Study Summary

A retrospective and prospective cohort, quantitative data collection with the goal of comparing preoperative High Resolution Manometry HRM results to Upper Gastrointestinal Marshmallow ,UGI MM results, in patients undergoing preoperative esophageal motility assessments. The aim of this study is to establish a correlation between HRM and UGI MM in order to create a clinically supported gold standard measurement for preoperative esophageal motility assessment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Preoperative patients who have undergone both HRM and UGI MM assessments as part oftheir preoperative plan of care.

  2. Patients who have had surgical procedures involving the upper GI tract and immediatesurrounding structures after completing HRM and UGI MM assessments preoperatively

  3. Adults age 18 and older

Exclusion

Exclusion Criteria:

  1. Patients who continued taking narcotics, calcium channel blockers, nitrates orpromotility medications the day of the HRM test, as these medications could falselyrelax or hyper stimulate esophageal structures.

  2. Patients with a past surgical history that includes Heller myotomy,peroralesophageal myotomy, botulinum injections, pneumatic dilations or gastricfundoplication

Study Design

Total Participants: 204
Study Start date:
August 24, 2022
Estimated Completion Date:
January 28, 2025

Study Description

Identifying esophageal motility disorders prior to surgical intervention is imperative when determining the procedural route that will produce the greatest positive patient outcome and reduce postoperative sequelae related to preoperative conditions. Possible disparities have been identified between HRM and UGI MM assessment results. Identifying testing variables and standards that could impact the obtained results will allow providers the ability to create a more customized plan of care and increase outcome predictability. Therefore, examining HRM and UGI MM level of agreement is essential to providing the best evidence-based practice care and meeting the unique needs of individual patients.

Currently, HRM results are noted as the standard benchmark for adequate assessment of esophageal motility function and disorders. Esophageal manometry testing provides a means to determine if the esophagus is functioning properly through a series of wet swallows. As a patient swallows, the esophagus contracts in a orderly sequence to push the swallowed contents to the stomach. Once the contents enter the stomach, the Lower Esophageal Sphincter, LES closes to prevent backflow or reflux of the stomach contents into the esophagus. Assessment of motility and sphincter function is vital prior to any surgical intervention that involves manipulation of the gastroesophageal junction,GEJ or surrounding structures. Inaccurate surgical manipulation can cause undesired pressure changes and alterations in normal peristalsis within the esophageal body. Any impairment to esophageal motility can compromise clearance and sphincter function, leading to adverse outcomes such as the development of intestinal metaplasia due to prolonged exposure of the mucosa to gastric acid

1.Patient Identification

  1. Patients undergoing esophageal motility evaluation prior to surgical intervention. Surgical interventions involve manipulation of the upper gastrointestinal tract and immediate surrounding structures.

  2. Patients undergoing procedures where the standard of care routinely includes preoperative motility assessment. These procedures include fundoplication procedures, open, laparoscopic and endoscopic and gastric sleeve or bypass candidates.

Connect with a study center

  • Lexington Health Incorporated

    West Columbia, South Carolina 29169
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.