- To identify endoscopic factors predicting positive outcomes: changes in hiatal hernia size [ Time Frame: change from baseline hiatal hernia size at 6 months ]
Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The size of a hiatal hernia is a parameter describing the continence characteristics of the sphincter neo-valve.
- To identify endoscopic factors predicting positive outcomes: changes in hiatal hernia size [ Time Frame: change from baseline hiatal hernia size at 12 months ]
Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The size of a hiatal hernia is a parameter describing the continence characteristics of the sphincter neo-valve.
- To identify endoscopic factors predicting positive outcomes: changes in Hill's grade [ Time Frame: change from baseline Hill's grade at 6 months ]
Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The Hill's grade is a parameter describing the continence characteristics of the sphincter neo-valve. The Hill's grade range from I to IV; the higher grades represents worse outcomes (worse valve's continence).
- To identify endoscopic factors predicting positive outcomes: changes in Hill's grade [ Time Frame: change from baseline Hill's grade at 12 months ]
Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The Hill's grade is a parameter describing the continence characteristics of the sphincter neo-valve. The Hill's grade range from I to IV; the higher grades represents worse outcomes (worse valve's continence).
- To identify endoscopic factors predicting positive outcomes: changes in Jobe's lenght [ Time Frame: change from baseline Jobe's lenght at 6 months ]
Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The Jobe's lenght is a parameter describing the continence characteristics of the sphincter neo-valve.
- To identify endoscopic factors predicting positive outcomes: changes in Jobe's lenght [ Time Frame: change from baseline Jobe's lenght at 12 months ]
Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The Jobe's lenght is a parameter describing the continence characteristics of the sphincter neo-valve.
- To identify endoscopic factors predicting positive outcomes: changes in esophagitis' grade [ Time Frame: change from baseline esophagitis' grade at 6 months ]
Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The presence of esophagitis and its grade, as defined by the Los Angeles classification, is a parameter of procedure's efficacy. The esophagitis grade range from A to D; the higher grades represents worse outcomes.
- To identify endoscopic factors predicting positive outcomes: changes in esophagitis' grade [ Time Frame: change from baseline esophagitis' grade at 12 months ]
Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The presence of esophagitis and its grade, as defined by the Los Angeles classification, is a parameter of procedure's efficacy. The esophagitis grade range from A to D; the higher grades represents worse outcomes.
- To identify pathophysiological factors predicting positive outcomes: changes in DeMeester score [ Time Frame: change from baseline DeMeester score at 6 months ]
parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux. DeMeester score is a composite score which examined six variables (number of reflux episodes, number of episodes longer than 5 minutes, longest reflux duration, total percentage of monitoring time with pH below 4, and the percentage of time with pH below 4 in an upright position and supine position). A score of >14.72 shows a pathological reflux. Higher values represent worse outcomes.
- To identify pathophysiological factors predicting positive outcomes: changes in DeMeester score [ Time Frame: change from baseline DeMeester score at 12 months ]
parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux. DeMeester score is a composite score which examined six variables (number of reflux episodes, number of episodes longer than 5 minutes, longest reflux duration, total percentage of monitoring time with pH below 4, and the percentage of time with pH below 4 in an upright position and supine position). A score of >14.72 shows a pathological reflux. Higher values represent worse outcomes.
- To identify pathophysiological factors predicting positive outcomes: changes in AET (Acid Exposure Time) [ Time Frame: change from baseline AET at 6 months ]
parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- To identify pathophysiological factors predicting positive outcomes: changes in AET (Acid Exposure Time) [ Time Frame: change from baseline AET at 12 months ]
parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- To identify pathophysiological factors predicting positive outcomes: changes in longest reflux episode (min) [ Time Frame: change from baseline longest reflux episode at 6 months ]
parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- To identify pathophysiological factors predicting positive outcomes: changes in longest reflux episode (min) [ Time Frame: change from baseline longest reflux episode at 12 months ]
parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- To identify pathophysiological factors predicting positive outcomes: changes in number of refluxes greater than 5 minutes [ Time Frame: change from baseline number of refluxes greater than 5 minutes at 6 months ]
parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- To identify pathophysiological factors predicting positive outcomes: changes in number of refluxes greater than 5 minutes [ Time Frame: change from baseline number of refluxes greater than 5 minutes at 12 months ]
parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- To identify pathophysiological factors predicting positive outcomes: changes in number of total refluxes [ Time Frame: change from baseline number of total refluxes at 6 months ]
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- To identify pathophysiological factors predicting positive outcomes: changes in number of total refluxes [ Time Frame: change from baseline number of total refluxes at 12 months ]
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- To identify pathophysiological factors predicting positive outcomes: changes in number of acid refluxes [ Time Frame: change from baseline number of acid refluxes at 6 months ]
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- To identify pathophysiological factors predicting positive outcomes: changes in number of acid refluxes [ Time Frame: change from baseline number of acid refluxes at 12 months ]
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- To identify pathophysiological factors predicting positive outcomes: changes in number of weakly acid refluxes [ Time Frame: change from baseline number of weakly acid refluxes at 6 months ]
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- To identify pathophysiological factors predicting positive outcomes: changes in number of weakly acid refluxes [ Time Frame: change from baseline number of weakly acid refluxes at 12 months ]
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- To identify pathophysiological factors predicting positive outcomes: changes in number of not acid refluxes [ Time Frame: change from baseline number of not acid refluxes at 6 months ]
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- To identify pathophysiological factors predicting positive outcomes: changes in number of not acid refluxes [ Time Frame: change from baseline number of not acid refluxes at 12 months ]
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- To identify pathophysiological factors predicting positive outcomes: changes in number of proximal refluxes [ Time Frame: change from baseline number of proximal refluxes at 6 months ]
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- To identify pathophysiological factors predicting positive outcomes: changes in number of proximal refluxes [ Time Frame: change from baseline number of proximal refluxes at 12 months ]
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- To identify pathophysiological factors predicting positive outcomes: changes in MNBI (Mean Nocturnal Baseline Impedance) [ Time Frame: change from baseline MNBI at 6 months ]
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- To identify pathophysiological factors predicting positive outcomes: changes in MNBI (Mean Nocturnal Baseline Impedance) [ Time Frame: change from baseline MNBI at 12 months ]
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- To identify pathophysiological factors predicting positive outcomes: changes in PSPW (Post Swallow reflux-induced Peristaltic Waves) [ Time Frame: change from baseline PSPW at 6 months ]
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- To identify pathophysiological factors predicting positive outcomes: changes in PSPW (Post Swallow reflux-induced Peristaltic Waves) [ Time Frame: change from baseline PSPW at 12 months ]
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- To identify pathophysiological factors predicting positive outcomes: changes in BCT (Bolus Clearance Time) [ Time Frame: change from baseline BCT at 6 months ]
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- To identify pathophysiological factors predicting positive outcomes: changes in BCT (Bolus Clearance Time) [ Time Frame: change from baseline BCT at 12 months ]
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) basal pressure [ Time Frame: change from baseline LES basal pressure at 6 months ]
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
- To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) basal pressure [ Time Frame: change from baseline LES basal pressure at 12 months ]
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
- To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) lenght [ Time Frame: change from baseline LES lenght at 6 months ]
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
- To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) lenght [ Time Frame: change from baseline LES lenght at 12 months ]
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
- To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) IRP (Integrated Relaxation Pressure) [ Time Frame: change from baseline LES IRP at 6 months ]
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
- To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) IRP (Integrated Relaxation Pressure) [ Time Frame: change from baseline LES IRP at 12 months ]
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
- To identify pathophysiological factors predicting positive outcomes: changes in DCI (Distal Contractile Integral) [ Time Frame: change from baseline DCI at 6 months ]
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
- To identify pathophysiological factors predicting positive outcomes: changes in DCI (Distal Contractile Integral) [ Time Frame: change from baseline DCI at 12 months ]
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
- To identify pathophysiological factors predicting positive outcomes: changes in rate of peristaltic waves [ Time Frame: change from baseline rate of peristaltic waves at 6 months ]
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
- To identify pathophysiological factors predicting positive outcomes: changes in rate of peristaltic waves [ Time Frame: change from baseline rate of peristaltic waves at 12 months ]
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
- To identify pathophysiological factors predicting positive outcomes: changes in rate of weak waves [ Time Frame: change from baseline rate of weak waves at 6 months ]
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
- To identify pathophysiological factors predicting positive outcomes: changes in rate of weak waves [ Time Frame: change from baseline rate of weak waves at 12 months ]
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
- To identify pathophysiological factors predicting positive outcomes: changes in rate of fragmented waves [ Time Frame: change from baseline rate of fragmented waves at 6 months ]
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
- To identify pathophysiological factors predicting positive outcomes: changes in rate of fragmented waves [ Time Frame: change from baseline rate of fragmented waves at 12 months ]
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
- To identify pathophysiological factors predicting positive outcomes: changes in rate of failed waves [ Time Frame: change from baseline rate of failed waves at 6 months ]
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
- To identify pathophysiological factors predicting positive outcomes: changes in rate of failed waves [ Time Frame: change from baseline rate of failed waves at 12 months ]
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.