NCT01602991 - Clinic-based Nasopharyngoesophagogastroscopy Following Bariatric Surgery | Crick

Overview

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

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 Type

INTERVENTIONAL

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Conditions

Obesity

Interventions

clinic-based nasopharyngoendoscopyPROCEDURE

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.

Standard EndoscopyPROCEDURE

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

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Outcomes

Primary Outcomes

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.

Time frame: Approximately 8 weeks

Secondary Outcomes

Complications of standard and in-office 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.

Time frame: approximately 8 weeks

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

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.

Time frame: Approximately 8 weeks

How well patients tolerate in-office 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.