Clinical trial NCT01815671: Evaluate the Safety and Diagnostic Advantages of Tilt Down Verses Standard Horizontal Colonoscopy Positioning
Official title: The Effect of Body Positioning for Colonoscopy in Women: Randomized, Study of Left Lateral Tilt Down Versus Left Lateral Horizontal Positioning
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diverticulosis
Keywords: colonoscopy
technique
tilt
insertion
safety
efficacy
Lead sponsor: Specialists in Gastroenterology, LLC
Sponsor class: OTHER
First posted: 2013-03-21
Enrollment: 173
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Who Experience Adverse Events Which Are Related or Possibly Related to the Colonoscopy Procedure
timeFrame: 24 hours
Secondary outcomes:
measure: Time to Full Colonoscope Insertion
timeFrame: 30 minutes
measure: Pain Related or Possibly Related to Colonoscopy Procedure
timeFrame: 24 hours
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Advanced Endoscopy Center
state: Missouri
Study officials:
affiliation: Specialists in Gastroenterology, LLC
name: Leonard B Weinstock, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weinstock LB. Body positions for colonoscopy: value of Trendelenburg. Gastrointest Endosc. 2009 Jun;69(7):1409-10. doi: 10.1016/j.gie.2008.09.039. No abstract available.