The Value of the Trendelenburg Position During Routine Colonoscopy: A Pilot Study.

Colonoscopy is a procedure commonly performed to screen for colon cancer and to look for and remove colon polyps. It involves inserting a flexible tube, equipped with a video-camera at the tip, through the colon. The insertion process can be difficult in some patients, resulting in an uncomfortable and lengthy procedure.We postulate that raising the foot of the bed so that the stretcher forms a 15 degrees angle with the floor ("Trendelenburg position") may make the colonoscopy easier and more comfortable to the patient.

Study Overview

• Status: Completed
• Conditions: Colonoscopy
• Intervention / Treatment: Procedure: Trendelenburg position; Procedure: Standard care

Detailed Description

Colonoscopy is a procedure commonly performed to screen for colon cancer and to look for and remove colon polyps. It involves inserting a flexible tube, equipped with a video-camera at the tip, through the colon. The insertion process can be difficult in some patients, resulting in an uncomfortable and lengthy procedure. Colonoscopy procedures are typically started with the patient positioned on their left side. If there is later difficulty advancing the colonoscope, the patient is shifted to other positions (e.g. back, right side, prone). We postulate that raising the foot of the bed so that the stretcher forms a 15 degrees angle with the floor ("Trendelenburg position") may make the colonoscopy easier and more comfortable to the patient. This is a position commonly used in gynecologic surgery. This is a pilot project for us to gain experience with doing colonoscopy this way. The enrolled patient will be assigned randomly to 2 groups: one in the standard left lateral position and one in the 15 degree Trendelenberg position. We will be collecting data regarding the procedure from each group in the form of questionnaire and data sheet which will be filled during or at the conclusion of the procedure.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient age between 18-75 years old.
• Colonoscopy performed for polyp surveillance or colon cancer screening purposes.
• Patient able to provide informed consent.

Exclusion Criteria:

• History of colon resection
• History of inflammatory bowel disease
• Pregnancy
• History of ischemic optic neuropathy or glaucoma
• Patient unable to provide informed consent
• Patients who did not fast for ≥2 hours prior to presenting for the procedure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trendelenburg position; The endoscopist places the patient in 15° Trendelenberg position immediately prior to the initiation of the colonoscopy.	Procedure: Trendelenburg position; The patient will be placed in the Trendelenburg position with a 15 degree angle of inclination; Other Names: Head-Down Tilt
Other: Standard care; The patient will have colonoscopy in the standard horizontal position	Procedure: Standard care; The patient will be placed in the standard horizontal position

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The time of the procedure from the insertion of the colonoscope until the cecal base is reached	This outcome is measured when the cecum is intubated during a colonoscopy

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Investigators: Principal Investigator: Abdo M Saad, MD, University of Missouri-Columbia

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: December 23, 2010
• First Submitted That Met QC Criteria: December 23, 2010
• First Posted (Estimate): December 24, 2010

Study Record Updates

• Last Update Posted (Estimate): October 3, 2016
• Last Update Submitted That Met QC Criteria: September 30, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 1173017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided