A Prospective Study Evaluating The Utility of Transnasal Endoscopy With Roux en Y Gastric Bypass
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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 |
- Anastomotic ulcer and diameter [ Time Frame: 1 year ] [ Designated as safety issue: No ]Presence of anastomic ulcer seen by slim scope
- 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:
|
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 |
This pilot study will attempt to recruit 20 subjects over one year.
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| Contact: Robin C Pope | 336-713-7336 | rpope@wakehealth.edu |
| Contact: John A Evans, MD | joevans@wakehealth.edu |
| 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 | |
| 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 University Baptist Medical Center:
|
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 May 22, 2013