Evaluate the Safety and Diagnostic Advantages of Tilt Down Verses Standard Horizontal Colonoscopy Positioning
- Conditions
- Diverticulosis
- Interventions
- Procedure: colonoscopy in the lateral horizontal position
- Registration Number
- NCT01815671
- Lead Sponsor
- Specialists in Gastroenterology, LLC
- 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 compared to lateral tilt down positioning for colonoscopy.
- 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 to either left lateral tilt down versus left lateral horizontal positioning to initiate colonoscopy.
Demographic data as well as routine information regarding the colonoscopy was filled out during or at the end of each procedure. In addition, the following parameters were assessed, and compared between groups:
1. Occurrence of complications related or possibly related to the colonoscopy procedure
2. Scope insertion time
3. Pain during and after the procedure
The subjects' participation was limited to the duration of the colonoscopy, which is typically less than 60 min and a follow up by telephone 24 hours later to assess the occurrence of complications.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 173
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lateral tilt down body position colonoscopy in the lateral horizontal position Subjects randomized to receive colonoscopy in the lateral tilt down position Lateral horizontal body position colonoscopy in the lateral horizontal position Subjects randomized to receive colonoscopy in the lateral horizontal position, This is the standard position. The other position - tilt down is the intervention
- Primary Outcome Measures
Name Time Method Number of Participants Who Experience Adverse Events Which Are Related or Possibly Related to the Colonoscopy Procedure 24 hours The number of participants who experience adverse events which are related or possibly related to the colonoscopy procedure will be tallied in each treatment arm.
- Secondary Outcome Measures
Name Time Method Time to Full Colonoscope Insertion 30 minutes Pain Related or Possibly Related to Colonoscopy Procedure 24 hours Visual Analogue Scale measured 0-4 with zero being no pain and 4 being most severe pain.
Trial Locations
- Locations (1)
Advanced Endoscopy Center
🇺🇸St. Louis, Missouri, United States