Status:
TERMINATED
Evaluate the Safety and Diagnostic Advantages of Tilt Down Verses Standard Horizontal Colonoscopy Positioning
Lead Sponsor:
Specialists in Gastroenterology, LLC
Conditions:
Diverticulosis
Eligibility:
FEMALE
18-90 years
Phase:
NA
Brief Summary
A tortuous sigmoid colon makes colonoscopy difficult. The purpose of this study was to systematically evaluate the diagnostic utility and incidence of adverse events in women using standard horizontal...
Detailed Description
This was a prospective, randomized study. Subjects who provide informed consent and present to the offices of Specialists in Gastroenterology for colonoscopy will be randomized in a 1:1 distribution t...
Eligibility Criteria
Inclusion
- ability to understand and sign consent
- women and men with a BMI (body mass index) \<35 kg/m2
- age 18 - 90 years
- no liquids by mouth for ≥2 hours
- no solid food for ≥8 hours
Exclusion
- inability to provide informed consent
- morbid obesity (BMI ≥35)
- pregnancy
- uncontrolled gastroesophageal reflux disease
- gastroparesis
- scleroderma
- achalasia
- Crohn's disease
- ulcerative colitis
- history of a colon resection
- Parkinson's disease
- brain tumor
- multiple sclerosis
- ischemic optic neuropathy
- glaucoma
- active pulmonary infection
- liquid intake \<2 hours
- solid food intake \<8 hours prior to the procedure
- intra-procedure findings of a stricture resulting in an incomplete colonoscopy or Boston bowel preparation scores of \<6
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT01815671
Start Date
May 1 2012
End Date
September 1 2012
Last Update
February 5 2014
Active Locations (1)
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1
Advanced Endoscopy Center
St Louis, Missouri, United States, 63141