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

Specialists in Gastroenterology, LLC

Status: Terminated

Conditions: Diverticulosis

Treatments: Procedure: colonoscopy in the lateral horizontal position

Study type: Interventional

Funder types: Other

Identifiers

NCT01815671

Leonard Weinstock, MD (Other Identifier)

BP-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 173 patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

173 participants in 2 patient groups

Lateral horizontal body position

Other group

Description:

Subjects randomized to receive colonoscopy in the lateral horizontal position, This is the standard position. The other position - tilt down is the intervention

Treatment:

Procedure: colonoscopy in the lateral horizontal position

Lateral tilt down body position

Other group

Description:

Subjects randomized to receive colonoscopy in the lateral tilt down position

Treatment:

Procedure: colonoscopy in the lateral horizontal position