Clinic-based Nasopharyngoesophagogastroscopy Following Bariatric Surgery

NCT ID: NCT01602991

Last Updated: 2015-09-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2013-05-31

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.

Conditions

Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

E.G. Scan

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vantage Endoscopy

UNKNOWN

Sponsor Role: collaborator

Dennis Hong MD

OTHER

Sponsor Role: lead

Responsible Party

Dennis Hong MD

PI

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dennis Hong, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

12-3647

Identifier Type: -

Identifier Source: org_study_id