Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06314893
Status:
RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-03-11
Brief Title:
Establishing a Correlation Between HRM and UGI MM Studies
Sponsor:
Lexington Health Incorporated
Organization:
Lexington Health Incorporated
Study Overview
Official Title:
Correlation of High Resolution Manometry and Upper Gastrointestinal Marshmallow Study in Preoperative Esophageal Motility Assessment
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MMvsMANO
Brief Summary:
A retrospective and prospective cohort quantitative data collection with the goal of comparing preoperative High Resolution ManometryHRM results to Upper Gastrointestinal MarshmallowUGI 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
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 disordersValdovinos-Garcia et at2019 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 SphincterLES 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 junctionGEJ 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 acidFalcao et al2020
1Patient 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 proceduresopen laparoscopic and endoscopic and gastric sleeve or bypass candidates
Currently HRM results are noted as the standard benchmark for adequate assessment of esophageal motility function and disordersValdovinos-Garcia et at2019 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 SphincterLES 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 junctionGEJ 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 acidFalcao et al2020
1Patient 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 proceduresopen laparoscopic and endoscopic and gastric sleeve or bypass candidates
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None