Evaluate the Safety and Diagnostic Advantages of Tilt Down Verses Standard Horizontal Colonoscopy Positioning

Study Overview
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Brief Summary
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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
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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: Occurrence of complications related or possibly related to the colonoscopy procedure Scope insertion time 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.

Official Title
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The Effect of Body Positioning for Colonoscopy in Women: Randomized, Study of Left Lateral Tilt Down Versus Left Lateral Horizontal Positioning

Conditions
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Diverticulosis

Intervention / Treatment
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* Procedure: colonoscopy in the lateral horizontal position


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Lateral horizontal body position<br>Subjects randomized to receive colonoscopy in the lateral horizontal position, This is the standard position. The other position - tilt down is the intervention | Procedure: colonoscopy in the lateral horizontal position<br>* colonoscopy in the lateral horizontal position with tilt down<br>|
| Other: Lateral tilt down body position<br>Subjects randomized to receive colonoscopy in the lateral tilt down position | Procedure: colonoscopy in the lateral horizontal position<br>* colonoscopy in the lateral horizontal position with tilt down<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Experience Adverse Events Which Are Related or Possibly Related to the Colonoscopy Procedure | 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. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Full Colonoscope Insertion |  | 30 minutes | 
| Pain Related or Possibly Related to Colonoscopy Procedure | Visual Analogue Scale measured 0-4 with zero being no pain and 4 being most severe pain. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insertion, colonoscopy, technique, tilt, safety, efficacy