Clinic-based Nasopharyngoesophagogastroscopy Following Bariatric Surgery (EGScan)
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This study aims to determine that this new technology, nasopharyngoendoscopy, is just as effective in diagnosing problems as the current gold standard.
Condition | Intervention |
---|---|
Obesity |
Procedure: clinic-based nasopharyngoendoscopy Procedure: Standard Endoscopy |
Study Type: | Interventional |
Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
Official Title: | Sensitivity, Specificity, and Positive and Negative Predictive Values of Clinic-based Nasopharyngoesophagogastroscopy Following Bariatric Surgery |
- 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 ] [ Designated as safety issue: No ]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.
- Complications of standard and in-office transnasal esophagoscopy [ Time Frame: approximately 8 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Approximately 8 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Immediately following transnasal esophagoscopy ] [ Designated as safety issue: No ]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.
Estimated Enrollment: | 120 |
Study Start Date: | May 2012 |
Estimated Study Completion Date: | May 2013 |
Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
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Procedure: clinic-based nasopharyngoendoscopy
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
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
Exclusion Criteria:
- Patients who have not undergone gastric bypass surgery
- Inability to give consent
Contact: Renee Shibish | 905-522-1155 | rshibish@stjoes.ca |
Contact: Karen Barlow | 905-522-1155 ext 35067 | kbarlow@mcmaster.ca |
Canada, Ontario | |
St. Joseph's Healthcare Hamilton | Not yet recruiting |
Hamilton, Ontario, Canada, L8N 4A6 | |
Principal Investigator: Dennis Hong, MD |
Principal Investigator: | Dennis Hong, MD | McMaster University |
No publications provided
Responsible Party: | Dennis Hong MD, PI, McMaster University |
ClinicalTrials.gov Identifier: | NCT01602991 History of Changes |
Other Study ID Numbers: | 12-3647 |
Study First Received: | May 7, 2012 |
Last Updated: | May 17, 2012 |
Health Authority: | Canada: Health Canada |
Keywords provided by McMaster University:
Obesity Endoscopy Nasopharyngoesophagogastroscopy Bariatric Surgery Gastric Bypass Surgery |
Additional relevant MeSH terms:
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on October 17, 2012