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

NCT ID: NCT01267123

Last Updated: 2016-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-02-29

Brief Summary

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.

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.

Conditions

Colonoscopy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Trendelenburg position

The endoscopist places the patient in 15° Trendelenberg position immediately prior to the initiation of the colonoscopy.

Group Type: EXPERIMENTAL

Trendelenburg position

Intervention Type: PROCEDURE

The patient will be placed in the Trendelenburg position with a 15 degree angle of inclination

Standard care

The patient will have colonoscopy in the standard horizontal position

Group Type: OTHER

Standard care

Intervention Type: PROCEDURE

The patient will be placed in the standard horizontal position

Interventions

Trendelenburg position

The patient will be placed in the Trendelenburg position with a 15 degree angle of inclination

Intervention Type: PROCEDURE

Standard care

The patient will be placed in the standard horizontal position

Intervention Type: PROCEDURE

Other Intervention Names

Head-Down Tilt

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Abdo M Saad, MD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Other Identifiers

1173017

Identifier Type: -

Identifier Source: org_study_id