Clinic-based Nasopharyngoesophagogastroscopy Following Bariatric Surgery (EGScan)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by McMaster University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Vantage Endoscopy
Information provided by (Responsible Party):
Dennis Hong MD, McMaster University
ClinicalTrials.gov Identifier:
NCT01602991
First received: May 7, 2012
Last updated: May 17, 2012
Last verified: May 2012
  Purpose

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

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)
Intervention Details:
    Procedure: clinic-based nasopharyngoendoscopy
    The study intervention is an in-office transnasal esophagoscopy. It is done in clinic, immediately after deciding the patient requires investigation of their upper gastrointestinal tract and the patient signs consent. The nasopharynx and oral pharynx is topically anesthetized. Since flexible scope is much thinner than a standard endoscopy, there is no requirement for intravenous sedation and thus, no requirement for specialized monitoring, nursing or recovery units. The procedure takes approximately 10 minutes. This study will be using the E.G. Scan II System.
    Other Name: E.G. Scan
    Procedure: Standard Endoscopy
    The control procedure is standard endoscopy. Endoscopy will be performed as per standard clinic practice. It is typically scheduled within 2 weeks of seeing the patient in clinic. The patient will be required to fast for 6 hours prior to the procedure. In most cases, patients will require intravenous sedation. If sedation is used, the patient will be required to take the day off work and have someone drive them home. This is the standard treatment for patients who present with upper gastrointestinal symptoms post-bariatric surgery. Patients who choose not to participate in this study will still undergo endoscopy as per standard clinical practice.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01602991

Contacts
Contact: Renee Shibish 905-522-1155 rshibish@stjoes.ca
Contact: Karen Barlow 905-522-1155 ext 35067 kbarlow@mcmaster.ca

Locations
Canada, Ontario
St. Joseph's Healthcare Hamilton Not yet recruiting
Hamilton, Ontario, Canada, L8N 4A6
Principal Investigator: Dennis Hong, MD         
Sponsors and Collaborators
Dennis Hong MD
Vantage Endoscopy
Investigators
Principal Investigator: Dennis Hong, MD McMaster University
  More Information

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 August 20, 2014