EGScan: Clinic-based Nasopharyngoesophagogastroscopy Following Bariatric Surgery

Sponsor

Dennis Hong MD (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01602991

Collaborator

Vantage Endoscopy (Other)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to determine that this new technology, nasopharyngoendoscopy, is just as effective in diagnosing problems as the current gold standard.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Procedure: clinic-based nasopharyngoendoscopy Procedure: Standard Endoscopy	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Sensitivity, Specificity, and Positive and Negative Predictive Values of Clinic-based Nasopharyngoesophagogastroscopy Following Bariatric Surgery

Study Start Date :

May 1, 2012

Anticipated Primary Completion Date :

May 1, 2013

Anticipated Study Completion Date :

May 1, 2013

Outcome Measures

Primary Outcome Measures

Sensitivity, specificity, and positive and negative predictive values of in-office transnasal esophagoscopy in evaluating symptomatic, post-operative bariatric surgery patients. [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 Outcome Measures

Complications of standard and in-office transnasal esophagoscopy [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.
Differences in in-hospital resource use between standard endoscopy and office-based transnasal nasopharyngoendoscopy [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.
How well patients tolerate in-office transnasal esophagoscopy [Immediately following transnasal esophagoscopy]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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