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

Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01267123
• Other study ID #: 1173017
• Status: Completed
• Phase: N/A
• First received: December 23, 2010
• Last updated: September 30, 2016
• Start date: January 2011
• Est. completion date: February 2012

Study information

• Verified date: September 2016
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: February 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Procedure:
• Trendelenburg position
The patient will be placed in the Trendelenburg position with a 15 degree angle of inclination
• Standard care
The patient will be placed in the standard horizontal position

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No