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

NCT01267123 | Completed

• 1 other identifier: 1173017
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colonoscopy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Trendelenburg position

EXPERIMENTAL

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

Procedure: Trendelenburg position

Standard care

OTHER

The patient will have colonoscopy in the standard horizontal position

Procedure: Standard care

Interventions

Trendelenburg position PROCEDURE

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

Also known as: Head-Down Tilt

Trendelenburg position

Standard care PROCEDURE

The patient will be placed in the standard horizontal position

Standard care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

MeSH Terms

Interventions

Head-Down Tilt; Standard of Care

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Abdo M Saad, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2010
• First Posted: December 24, 2010
• Study Start: January 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: February 1, 2012
• Last Updated: October 3, 2016

Record last verified: 2016-09