Sensitivity, Specificity, and Positive and Negative Predictive Values of Clinic-based Nasopharyngoesophagogastroscopy Following Bariatric Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- Dennis Hong MD
- Locations
- 1
- Primary Endpoint
- Sensitivity, specificity, and positive and negative predictive values of in-office transnasal esophagoscopy in evaluating symptomatic, post-operative bariatric surgery patients.
- Status
- Withdrawn
- Last Updated
- 10 years ago
Overview
Brief Summary
This study aims to determine that this new technology, nasopharyngoendoscopy, is just as effective in diagnosing problems as the current gold standard.
Detailed Description
Obesity is a public health problem. Currently, the best treatment is surgery. However, 15% of patients after surgery have problems such as nausea, pain, vomiting, heartburn or regurgitation. To investigate these problems, an endoscopy is used. Yet, endoscopy has some disadvantages such as the need for intravenous sedation, need to take time off work, need for special endoscopy units and nurses and a delay in diagnosing because the endoscopy cannot be done at the time of the clinic visit. A new technology called clinic-based nasopharyngoendoscopy can potentially solve many of the problems with the current endoscopy. This study aims to determine that this new technology is just as effective in diagnosing problems as the current gold standard.
Investigators
Dennis Hong MD
PI
McMaster University
Eligibility Criteria
Inclusion Criteria
- •Post-operative gastric bypass patients at St. Joseph's Healthcare Hamilton
- •No previous nasal or pharyngeal surgery
- •Foregut dyspeptic symptoms including: nausea, vomiting, regurgitation, epigastric pain, reflux and/or hematemesis
- •Require endoscopy for investigation of foregut symptoms
- •Able to provide consent
Exclusion Criteria
- •Patients who have not undergone gastric bypass surgery
- •Inability to give consent
Outcomes
Primary Outcomes
Sensitivity, specificity, and positive and negative predictive values of in-office transnasal esophagoscopy in evaluating symptomatic, post-operative bariatric surgery patients.
Time Frame: Approximately 8 weeks
The patients will receive transnasal esophagoscopy, then standard endoscopy approximately 2 weeks later. Patients will return to the bariatric clinic 2-4 weeks after standard endoscopy to review the results of both procedures and discuss possible treatment. Patients will not be required to undergo any further study-related follow-up or complete any questionnaires.
Secondary Outcomes
- Complications of standard and in-office transnasal esophagoscopy(approximately 8 weeks)
- How well patients tolerate in-office transnasal esophagoscopy(Immediately following transnasal esophagoscopy)
- Differences in in-hospital resource use between standard endoscopy and office-based transnasal nasopharyngoendoscopy(Approximately 8 weeks)