Establishing a Correlation Between HRM and UGI MM Studies

NCT06314893 | Terminated

• 1 other identifier: LMCII2022-001
• Study Type: observational
• Target: 204
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Motility Disorders

Keywords

GI tract

Outcome Measures

Primary Outcomes (1)

• 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.

  June 2021 -July 2025

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.
• Patients with a past surgical history that includes Heller myotomy, peroralesophageal myotomy, botulinum injections, pneumatic dilations or gastric fundoplication

Sponsors & Collaborators

• Lexington Health Incorporated: lead

Study Sites (1)

Lexington Health Incorporated

West Columbia, South Carolina, 29169, United States

Location

Related Publications (3)

• Yadlapati R. High-resolution esophageal manometry: interpretation in clinical practice. Curr Opin Gastroenterol. 2017 Jul;33(4):301-309. doi: 10.1097/MOG.0000000000000369.

  PMID: 28426462 BACKGROUND

• FalcAo AM, Nasi A, Szachnowicz S, Santa-Cruz F, Seguro FCBC, Sena BF, Duarte A, Sallum RA, Cecconello I. Does the nissen fundoplication procedure improve esophageal dysmotility in patients with barrett's esophagus? Rev Col Bras Cir. 2020 Nov 30;47:e20202637. doi: 10.1590/0100-6991e-20202637. eCollection 2020. English, Portuguese.

  PMID: 33263652 BACKGROUND

• Musella M, Vitiello A, Berardi G, Velotti N, Pesce M, Sarnelli G. Evaluation of reflux following sleeve gastrectomy and one anastomosis gastric bypass: 1-year results from a randomized open-label controlled trial. Surg Endosc. 2021 Dec;35(12):6777-6785. doi: 10.1007/s00464-020-08182-3. Epub 2020 Dec 2.

  PMID: 33269429 BACKGROUND

Related Links

• Esophageal Manometry

MeSH Terms

Conditions

Esophageal Motility Disorders

Condition Hierarchy (Ancestors)

Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Marc Antonetti, MD

  Lexington Health Incorporated

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 18, 2024
• Study Start: August 24, 2022
• Primary Completion: January 28, 2025
• Study Completion: January 28, 2025
• Last Updated: April 17, 2025

Record last verified: 2024-03

Locations

US (1)