Clinic-based Nasopharyngoesophagogastroscopy Following Bariatric Surgery

NCT01602991 | Withdrawn

• 1 other identifier: 12-3647
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity

Keywords

Obesity; Endoscopy; Nasopharyngoesophagogastroscopy; Bariatric Surgery; Gastric Bypass Surgery

Outcome Measures

Primary Outcomes (1)

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

  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.

  Approximately 8 weeks

Secondary Outcomes (3)

• Complications of standard and in-office transnasal esophagoscopy

  approximately 8 weeks

• Differences in in-hospital resource use between standard endoscopy and office-based transnasal nasopharyngoendoscopy

  Approximately 8 weeks

• How well patients tolerate in-office transnasal esophagoscopy

  Immediately following transnasal esophagoscopy

Interventions

clinic-based nasopharyngoendoscopy PROCEDURE

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.

Also known as: E.G. Scan

Standard Endoscopy PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who have not undergone gastric bypass surgery
• Inability to give consent

Sponsors & Collaborators

• Dennis Hong MD: lead
• Vantage Endoscopy: collaborator

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dennis Hong, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: May 7, 2012
• First Posted: May 21, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: September 24, 2015

Record last verified: 2015-09

Locations

CA (1)