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Completed

NCT Number: NCT01526772

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

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

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

endoscopy

Procedure

Transoral endoscopy versus transoral endoscopy

Other names: Endoscopy performed transnasally with a slim scope, Transoral endoscopy with a routine diagnostic endoscope

Primary outcomes

  1. Anastomotic ulcer and diameter

    Time frame: 1 year

    Presence of anastomic ulcer seen by slim scope

Secondary outcomes

  1. Presence of anastomotic stricture and diameter

    Time frame: 1 years

    Presence of anastomotic sticture seen by slim scope and estimated anastomis diameter

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Feb 6, 2012
Registry last updated
Nov 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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