The Value of the Trendelenburg Position During Routine Colonoscopy: A Pilot Study.
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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. |
- 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 |
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| Contact: Abdo M Saad, MD | 573-882-8586 | saada@health.missouri.edu |
| 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 June 13, 2013