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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by University of Missouri-Columbia.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT01267123
First received: December 23, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Focus of the Study:
Head-Down Tilt
Colonoscopy
Other: Trendelenburg position

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: The Value of the Trendelenburg Position During Routine Colonoscopy: A Pilot Study.

Resource links provided by NLM:


Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • The time of the procedure from the insertion of the colonoscope until the cecal base is reached [ Time Frame: This outcome is measured when the cecum is intubated during a colonoscopy ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trendelenburg position Other: Trendelenburg position
The patient will be placed in the Trendelenburg position with a 15 degree angle of inclination
Other Name: Head-Down Tilt

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01267123

Contacts
Contact: Abdo M Saad, MD 573-882-8586 saada@health.missouri.edu

Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Abdo M Saad, MD University of Missouri-Columbia
  More Information

No publications provided

Responsible Party: Abdo Saad, MD, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT01267123     History of Changes
Other Study ID Numbers: 1173017
Study First Received: December 23, 2010
Last Updated: December 23, 2010
Health Authority: USA: Institutional Review Board

ClinicalTrials.gov processed this record on August 28, 2014