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

Not Applicable
Terminated
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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Lateral tilt down body positioncolonoscopy in the lateral horizontal positionSubjects randomized to receive colonoscopy in the lateral tilt down position
Lateral horizontal body positioncolonoscopy in the lateral horizontal positionSubjects 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
NameTimeMethod
Number of Participants Who Experience Adverse Events Which Are Related or Possibly Related to the Colonoscopy Procedure24 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
NameTimeMethod
Time to Full Colonoscope Insertion30 minutes
Pain Related or Possibly Related to Colonoscopy Procedure24 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

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