跳至主要内容
临床试验/NCT06314893
NCT06314893终止不适用

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

Lexington Health Incorporated1 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2022年8月24日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
204
试验地点
1
主要终点
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.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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.

时间窗: June 2021 -July 2025

次要结局

未报告次要终点

研究者

发起方
Lexington Health Incorporated
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marc Antonetti, MD

Principal Investigator

Lexington Health Incorporated

研究点 (1)

Loading locations...

相似试验