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Patient Position and Impact on Colonoscopy Time

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00314418
First Posted: April 13, 2006
Last Update Posted: April 13, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
VA Office of Research and Development
Information provided by:
VA Connecticut Healthcare System
  Purpose

Colonoscopy is usually associated with coiling ("looping") of the colonoscope (instrument used for the procedure) in parts of the bowel. This is the main reason for patient discomfort and lengthens the duration of the procedure. Minimizing the coiling of the colonoscope would decrease the duration, and improve the efficiency and tolerability of the procedure and have a positive impact on colon cancer screening.

The primary aim of this study is to compare the time it takes for the colonoscope to reach the end of the colon when the patient is lying on the belly versus the left side (usual) at the start of the procedure. Patients who have medical conditions that may be affected by lying on their belly or those who cannot comfortably lie on the belly will be excluded from the study. Changes in patient position and use of abdominal pressure (commonly given by the endoscopy nurse during the procedure) will be permitted as necessary and determined by the endoscopist. The endoscopist will also retain the decision to discontinue the patient's participation from the study for any medical reason. After the procedure the patient will be monitored in the usual manner and asked to fill out a "satisfaction survey" (24 hours after).


Condition Intervention
Colonoscopy Procedure: Colonoscopy in the prone position

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Patient Position and Impact on Colonoscopic Cecal Intubation Time

Resource links provided by NLM:


Further study details as provided by VA Connecticut Healthcare System:

Primary Outcome Measures:
  • Colonoscopic Cecal Intubation time

Secondary Outcome Measures:
  • Total colonoscopy time, colonoscope withdrawal time, cumulative sedation dose, recovery time, need for abdominal pressure and changes in patient position during the procedure, adenoma prevalence rate, complications, patient satisfaction.

Estimated Enrollment: 120
Study Start Date: September 2005
Estimated Study Completion Date: March 2006
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Male Veterans presenting for outpatient colonoscopy for any indication.

Exclusion Criteria:

  • Severe Congestive heart failure with left Ventricular ejection fraction <30%,
  • Severe Chronic Obstructive lung disease dependant on Home Oxygen or recent decompensation,
  • Spine disease or other condition with difficulty laying in the prone position.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00314418


Locations
United States, Connecticut
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
VA Connecticut Healthcare System
VA Office of Research and Development
Investigators
Principal Investigator: Shivakumar Vignesh, MD VA Connecticut Healthcare System
  More Information

ClinicalTrials.gov Identifier: NCT00314418     History of Changes
Other Study ID Numbers: SV0001
Digestive Disease
First Submitted: April 11, 2006
First Posted: April 13, 2006
Last Update Posted: April 13, 2006
Last Verified: April 2006

Keywords provided by VA Connecticut Healthcare System:
Colonoscopy
technique
time
duration
position
abdominal pressure


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