Upper GI MM vs Manometry

NCT06973070 | Completed

• 1 other identifier: LMCII2025-003
• Study Type: observational
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

Research will consist of retrospective review of prospective cohort quantitative data collection with the goal of comparing preoperative High-Resolution Manometry (HRM) results to Upper Gastrointestinal Marshmallow (UGIMM) results, in the patient undergoing preoperative esophageal motility assessment. The aim of this study is to establish a correlation between HRM and UGIMM studies in order to create a clinically supported gold standard measurement for preoperative esophageal motility assessment. Research will examine the level of reliability and variability of the esophageal motility assessment conducted utilizing HRM and the UGIMM study. Standards of testing and current practice guidelines will be reviewed and compared for correlations in procedure outcomes. Research seeks to accomplish validation and strengthening of current practices related to the use and interpretation of HRM and UGIMM study results as a valid postoperative outcome predictor.

Conditions

GERD (Gastroesophageal Reflux Disease)

Keywords

GERD REFLUX GASTRIC REFLUX

Outcome Measures

Primary Outcomes (1)

• The aim of this study is to establish a correlation between High Resolution Manometry and Upper Gastrointestinal Marshmallow studies to create a clinically supported gold standard measurement for preoperative esophageal motility assessment

  Research will examine the level of reliability and variability of the esophageal motility assessment conducted utilizing High Resolution Manometry and the Upper Gastrointestinal Marshmallow study. Standards of testing and current practice guidelines will be reviewed and compared for correlations in procedure outcomes. Research seeks to accomplish validation and strengthening of current practices related to the use and interpretation of High Resolution Manometry and Upper Gastrointestinal Marshmallow study results as a valid postoperative outcome predictor.

  September 2020-April 2024

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 UGIMM 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 UGIMM assessments preoperatively.
• Adults aged 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 (Snyder \& Ravi, 2021).
• Patients with a past surgical history that includes Heller myotomy, peroral esophageal 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)

• 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

• 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

• 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

Related Links

• Related Info

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; 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: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 15, 2025
• Study Start: March 17, 2025
• Primary Completion: March 20, 2025
• Study Completion: March 20, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-03

Locations

US (1)