Establishing a Correlation Between HRM and UGI MM Studies (MMvsMANO)

April 14, 2025 updated by: Marc Antonetti, MD, Lexington Health Incorporated

Correlation of High Resolution Manometry and Upper Gastrointestinal Marshmallow Study in Preoperative Esophageal Motility Assessment

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.

Study Overview

Status

Terminated

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

204

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • West Columbia, South Carolina, United States, 29169
        • Lexington Health Incorporated

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing preoperative testing for surgical intervention involving manipulation of the upper gastrointestinal tract.

Description

Inclusion Criteria:

  1. Preoperative patients who have undergone both HRM and UGI MM assessments as part of their preoperative plan of care.
  2. Patients who have had surgical procedures involving the upper GI tract and immediate surrounding structures after completing HRM and UGI MM assessments preoperatively
  3. Adults age 18 and older

Exclusion Criteria:

  1. Patients who continued taking narcotics, calcium channel blockers, nitrates or promotility medications the day of the HRM test, as these medications could falsely relax or hyper stimulate esophageal structures.
  2. Patients with a past surgical history that includes Heller myotomy, peroralesophageal myotomy, botulinum injections, pneumatic dilations or gastric fundoplication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determining the correlation between HRM and UGI MM assessments among preoperative candidates will provide an evidenced based evaluation strategy for establishing procedural candidacy and predicting postoperative outcomes.
Time Frame: June 2021 -July 2025
June 2021 -July 2025

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lexington Health Incorporated

Investigators

  • Principal Investigator: Marc Antonetti, MD, Lexington Health Incorporated

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2022

Primary Completion (Actual)

January 28, 2025

Study Completion (Actual)

January 28, 2025

Study Registration Dates

First Submitted

March 11, 2024

First Submitted That Met QC Criteria

March 11, 2024

First Posted (Actual)

March 18, 2024

Study Record Updates

Last Update Posted (Actual)

April 17, 2025

Last Update Submitted That Met QC Criteria

April 14, 2025

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LMCII2022-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Esophageal Motility Disorders

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe