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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Wake Forest Baptist Health.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Jerry Evans, Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier:
NCT01526772
First received: January 17, 2012
Last updated: February 1, 2012
Last verified: February 2012
  Purpose

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


Condition Intervention
Obesity
Procedure: Endoscopy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study Evaluating The Utility of Transnasal Endoscopy With Roux en Y Gastric Bypass Referred for Upper Endoscopy

Resource links provided by NLM:


Further study details as provided by Wake Forest Baptist Health:

Primary Outcome Measures:
  • Anastomotic ulcer and diameter [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Presence of anastomic ulcer seen by slim scope


Secondary Outcome Measures:
  • Presence of anastomotic stricture and diameter [ Time Frame: 1 years ] [ Designated as safety issue: No ]
    Presence of anastomotic sticture seen by slim scope and estimated anastomis diameter


Estimated Enrollment: 20
Study Start Date: September 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients who have undergone RYGB
Patients who have undergone RYGB and have been referred for an EGD
Procedure: Endoscopy
Transoral endoscopy versus transoral endoscopy
Other Names:
  • Endoscopy performed transnasally with a slim scope
  • Transoral endoscopy with a routine diagnostic endoscope

Detailed Description:

Obesity is an epidemic in the United States effecting 250 million people worldwide and over 30% of the population of the United Sates. Medical therapy for obesity is lacking in its durability in maintaining weight loss. Currently surgical therapy is the most dependable and durable treatment option. The Roux en Y gastric bypass (RYGB) was initially described in 1967 and is currently the surgical method of choice in the treatment of obesity. It involves the creation of a small gastric pouch by restricting the gastric body and antrum and the creation of a long roux limb with a gastrojejunal anastomosis, thus inducing satiety and creating a malabsorptive physiology. Unfortunately this procedure maintains a significant complication rate. Strictures at the gastrojejunal anastomosis occur in 6-20% of patients after bypass.1 Anastomotic ulcers occur in up to 16% .2 Symptoms include vomiting, abdominal pain, and significant nausea. Unfortunately these symptoms are not specific to strictures or ulcers and may occur spontaneously without a specific etiology, so often a transoral upper endoscopy (EGD) is required to evaluate the anastomosis for significant pathology.

EGD in post bariatric patients is a safe procedure. However it typically requires deep sedation administered by an anesthesiologist to overcome the patient's gag reflex and discomfort. Sedation in obese patients can be challenging due to the risks of apnea and challenges of tracheal intubation. For the procedure to be performed the patient must take the day off from work and bring a driver to take them home, thus there are significant direct and indirect costs to the procedure.

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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients who cannot give and sign informed 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: NCT01526772

Contacts
Contact: Robin C Pope 336-713-7336 rpope@wakehealth.edu
Contact: John A Evans, MD joevans@wakehealth.edu

Locations
United States, North Carolina
Wake Forest Baptist Health Recruiting
Winston Salem, North Carolina, United States, 27157
Contact: Robin C Pope    336-713-7336    rpope@wakehealth.edu   
Contact: Jerry Evans, MD       joevans@wakehealth.edu   
Principal Investigator: John A Evans, MD         
Sponsors and Collaborators
Wake Forest Baptist Health
Investigators
Principal Investigator: John O Evans, MD Wake Forest University Baptist Health
  More Information

No publications provided

Responsible Party: Jerry Evans, MD, Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier: NCT01526772     History of Changes
Other Study ID Numbers: IRB00018487
Study First Received: January 17, 2012
Last Updated: February 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest Baptist Health:
Transnasal
Transoral
Roux en Y gastric bypass
Upper Endoscopy
Obesity

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 29, 2014