A Prospective Study Evaluating The Utility of Transnasal Endoscopy With Roux en Y Gastric Bypass

NCT01526772 | Completed

• 1 other identifier: IRB00018487
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Improvements in imaging technology have allowed for the development of small endoscopes ("slim scopes") half the size of a typical endoscope. These small endoscopes can be passed transnasally into the esophagus and stomach with only local anesthesia to the nasal passage without the need for deep sedation. They have been used in the detection of diseases of the esophagus and stomach,3,4 but have not been used in the detection of complications in the post bariatric population

Conditions

Obesity

Keywords

Transnasal; Transoral; Roux en Y gastric bypass; Upper Endoscopy; Obesity

Outcome Measures

Primary Outcomes (1)

• Anastomotic ulcer and diameter

  Presence of anastomic ulcer seen by slim scope

  1 year

Secondary Outcomes (1)

• Presence of anastomotic stricture and diameter

  1 years

Study Arms (1)

Patients who have undergone RYGB

Patients who have undergone RYGB and have been referred for an EGD

Procedure: Endoscopy

Interventions

Endoscopy PROCEDURE

Transoral endoscopy versus transoral endoscopy

Also known as: Endoscopy performed transnasally with a slim scope, Transoral endoscopy with a routine diagnostic endoscope

Patients who have undergone RYGB

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This pilot study will attempt to recruit 20 subjects over one year.

You may qualify if:

• Subjects must be able to review and sign informed consent
• Subjects have undergone Roux en Y gastric bypass
• Subjects report any of the following symptoms that would prompt investigation and referral for an upper endoscopy; abdominal pain, nausea, vomiting or problems swallowing

You may not qualify if:

• Patients who cannot give and sign informed consent.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• John O Evans, MD

  Wake Forest University Baptist Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2012
• First Posted: February 6, 2012
• Study Start: September 1, 2011
• Primary Completion: July 7, 2014
• Study Completion: July 7, 2014
• Last Updated: November 7, 2017

Record last verified: 2017-04

Locations

US (1)