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

NCT ID: NCT01815671

Last Updated: 2014-02-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 173 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2012-09-30

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.

Conditions

Diverticulosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

Lateral horizontal body position

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

Group Type: OTHER

colonoscopy in the lateral horizontal position

Intervention Type: PROCEDURE

colonoscopy in the lateral horizontal position with tilt down

Lateral tilt down body position

Subjects randomized to receive colonoscopy in the lateral tilt down position

Group Type: OTHER

colonoscopy in the lateral horizontal position

Intervention Type: PROCEDURE

colonoscopy in the lateral horizontal position with tilt down

Interventions

colonoscopy in the lateral horizontal position

colonoscopy in the lateral horizontal position with tilt down

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Specialists in Gastroenterology, LLC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leonard B Weinstock, MD

Role: PRINCIPAL_INVESTIGATOR

Specialists in Gastroenterology, LLC

Locations

Advanced Endoscopy Center

St Louis, Missouri, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 19481671 (View on PubMed)

Other Identifiers

Leonard Weinstock, MD

Identifier Type: OTHER

Identifier Source: secondary_id

BP-1

Identifier Type: -

Identifier Source: org_study_id