A retrospective analysis of a prospectively collected database on the safety and effectiveness of preemptive esophageal dilatation in the management of high-grade food bolus obstruction in the upper esophagus

Not Applicable

Completed

• Conditions: Food bolus obstruction; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12621001437853
• Lead Sponsor: Royal Adelaide Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-09-30
• Study Start: 2021-10-25
• Last Update Posted: 1 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 456

Inclusion Criteria

•Age 18-90 years
•Confirmed acute food bolus requiring endoscopy

Exclusion Criteria

• Age <18
• Patients managed medically, not requiring endoscopic retrieval of food bolus

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety of esophageal dilation assessed through medical records and hospital admissions records.[48 hours after procedure];Safety, devoid of any procedure related complications assessed through hospital records and patient reporting.<br>Adverse events or Complications are defined as procedure related complications from esophageal dilation which are bleeding and perforation.<br>-Bleeding is categorized into (i)minor bleeding”- transient bleeding that spontaneously resolved without requirement of blood transfusion or intervention to stop bleeding OR (ii) major bleeding”- persistent bleeding leading to hemodynamic instability and requirement of blood transfusion and intervention to cease bleeding such as radiologic embolization or endoscopic hemostasis.<br>-Perforation is defined as iatrogenic esophageal mucosal tear with direct communication with mediastinum or peritoneum the after esophageal dilation evident on endoscopic view[48 hours after procedure]

Secondary Outcome Measures

Name	Time	Method
Effectiveness of esophageal dilation in reducing recurrent FBO will be defined as the ability of the endoscope to traverse the esophageal stenosis after dilation and ability to reduce the number of recurrent food bolus obstruction, this will be assessed through medical records and hospital admissions.<br><br>[Within 48 hours of procedure];-Esophageal Structural abnormalities defined as obvious esophageal pathologies including peptic stricture, eosinophilic esophagitis and schatzki rings that is evident during endoscopy<br>[Within 48 hours of procedure<br>];Total endoscopy time, this will be assessed through data-linkage to medical records.<br><br>-Total endoscopy time is defined as the time when the first endoscopic dilator is inserted into the oral cavity to the time when the last dilator is removed from the oral cavity[Within 48 hours of procedure]