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Trendelenberg Versus Left Lateral Position for Colonoscopy

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ClinicalTrials.gov Identifier: NCT02519686
Recruitment Status : Completed
First Posted : August 11, 2015
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
The purpose of this study is to determine if the trendelenberg (TD) position (position in procedures that involves placing the patient at an angle so that their head is lower than their feet on the procedure bed) in select patients undergoing colonoscopy is superior than the left lateral (LL) position (patient laying on their side, traditionally used for colonoscopies) in terms of decreasing time necessary to pass the colonoscope through the left colon, and decreasing the difficulty of the procedure.

Condition or disease
Colonic Diseases

Detailed Description:

The colonoscopists will be asked to rate their prediction of difficulty of the procedure prior to the colonoscopy and to rate the ease of procedure after the colonoscopy. The clinical experience of the study investigators is that TD positioning is superior to LL positioning in patients with risk factors for having a difficult colonoscopy (thin women; those with diverticulosis- small bulging pouches present in the colon; or prior pelvic surgery).

Patients with risk factors for difficult colonoscopy will be randomized to undergo colonoscopy while positioned in the TD position or the LL position during advancement of the colonoscope through the sigmoid colon. The sigmoid colon is a section of the colon, proximal to the rectum, that is curved. The sigmoid colon is a normal component of GI tract anatomy, although due to it's shape, especially with the risk factors listed previously; can cause challenges to inserting the colonoscope.

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Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Impact of Trendelenberg Positioning as Compared to Left Lateral Positioning on Ease of Colonoscope Insertion During Colonoscopy
Study Start Date : July 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Group/Cohort
Trendelenburg position maneuver
Trendelenburg (TD) positioning (supine with head tilt-down) is used in abdominal and gynecological surgery as well as during colonoscopy to allow better access to the pelvic organs, as gravity pulls the bowel out of the pelvic cavity and the rectosigmoid angle straightens.
Left lateral position maneuver
Left Lateral (LL) position (patient laying on their side, traditionally used for colonoscopies)



Primary Outcome Measures :
  1. Cecal insertion time [ Time Frame: intraoperaive ]
    The time from scope insertion to the cecum



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults
Criteria

Inclusion Criteria:

  1. Personal history of pelvic surgery
  2. Diverticulosis, identified by patient report or review of previous colonoscopy or imaging studies.
  3. BMI < 25.

Exclusion Criteria:

  1. Patients who do not meet inclusion criteria.
  2. Patients who have undergone colonic resection
  3. Patients with glaucoma
  4. Patients with uncontrolled acid reflux disease or active nausea/vomiting.
  5. Patients who are unwilling or unable to consent.
  6. BMI > 30

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): NCT02519686


Locations
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United States, Missouri
Washington University in St Louis School of Medicine
St Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Dayna S Early, MD Washington University School of Medicine
Publications:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02519686    
Other Study ID Numbers: 201504136
First Posted: August 11, 2015    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases