Colonoscopy in the Prone Position for Patients With BMI Greater Than 30
NCT ID: NCT03337217
Last Updated: 2019-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
141 participants
INTERVENTIONAL
2017-12-10
2019-06-10
Brief Summary
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The investigators plan to randomize patients with Body Mass Index \>30 that are presenting to the University of Virginia for colonoscopy to either the prone or left lateral decubitus position. The investigators will then record and compare cecal intubation times as well as amount of sedation used and complications to help determine which position is superior for this patient population.
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Detailed Description
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After randomization, patients will begin the colonoscopy in either the prone position or left lateral decubitus position.
It is common practice to re-position the patient during endoscopy (including supine and prone positions) and some endoscopists commonly employ prone starting position for obese patients, although there is no estimate in the literature as to the prevalence of this practice.
No additional interventions will be performed for research purposes. During the colonoscopy, the endoscopist will be allowed, as usual, to adjust patient position as needed to complete the procedure. Cecal intubation time, amount of sedation used, and any intra-procedural complications (hypoxia, hypotension, etc) will be recorded for data analysis. This information is standardly recorded in the procedure report in the patient's medical record. The study will not affect any interventions performed during the colonoscopy such as polyp removal or biopsies as, clinically indicated. Per endoscopy unit protocol, patients will be monitored in the recovery area and discharged home with supervision. The study requires no further direct patient interaction after the colonoscopy is completed. Charts will be reviewed at 30 days to assess for any delayed and unexpected complications.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Prone Position
Position during colonoscopy
Position during colonoscopy
Position during colonoscopy
Left lateral decubitus position
Position during colonoscopy
Position during colonoscopy
Position during colonoscopy
Interventions
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Position during colonoscopy
Position during colonoscopy
Eligibility Criteria
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Inclusion Criteria
* Undergoing screening or diagnostic colonoscopy with conscious sedation
Exclusion Criteria
* Cognitively impaired patients
* History of colonic resection
* Cannot lay in prone position
* History of colon malignancy
* Procedure aborted due to inadequate bowel prep
* Severe pulmonary problems (including baseline oxygen use)
* Inability to provide consent for themselves
18 Years
90 Years
ALL
Yes
Sponsors
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University of Virginia
OTHER
Responsible Party
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Brooke Corning
Principal Investigator, Fellow Physician, Dept of Internal Medicine Division of Gastroenterology and Hepatology
Principal Investigators
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Brooke Corning, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia, Dept of Internal Medicine, Divison of Gastroenterology and Hepatology
Locations
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University of Virginia
Charlottesville, Virginia, United States
Countries
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References
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Uddin FS, Iqbal R, Harford WV, Dunbar KB, Cryer BL, Spechler SJ, Feagins LA. Prone positioning of obese patients for colonoscopy results in shortened cecal intubation times: a randomized trial. Dig Dis Sci. 2013 Mar;58(3):782-7. doi: 10.1007/s10620-012-2468-x. Epub 2012 Nov 10.
Weinstock LB, Early DS. Colonoscopy in the tilt-down position. Gastrointest Endosc. 2014 Oct;80(4):746. doi: 10.1016/j.gie.2014.05.328. No abstract available.
Rex DK. Achieving cecal intubation in the very difficult colon. Gastrointest Endosc. 2008 May;67(6):938-44. doi: 10.1016/j.gie.2007.12.028. No abstract available.
De Silva AP, Kumarasena RS, Perera Keragala SD, Kalubowila U, Niriella M, Dassanayake AS, Pathmeswaran A, de Silva HJ. The prone 12 o'clock position reduces ileal intubation time during colonoscopy compared to the left lateral 6 o'clock (standard) position. BMC Gastroenterol. 2011 Aug 4;11:89. doi: 10.1186/1471-230X-11-89.
Vergis N, McGrath AK, Stoddart CH, Hoare JM. Right Or Left in COLonoscopy (ROLCOL)? A Randomized Controlled Trial of Right- versus Left-Sided Starting Position in Colonoscopy. Am J Gastroenterol. 2015 Nov;110(11):1576-81. doi: 10.1038/ajg.2015.298. Epub 2015 Sep 29.
Lucendo AJ. Colonoscopy in obese patients: time to change position. Dig Dis Sci. 2013 Mar;58(3):608-9. doi: 10.1007/s10620-012-2542-4. Epub 2013 Jan 12. No abstract available.
Lieberman DA, Rex DK, Winawer SJ, Giardiello FM, Johnson DA, Levin TR. Guidelines for colonoscopy surveillance after screening and polypectomy: a consensus update by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2012 Sep;143(3):844-857. doi: 10.1053/j.gastro.2012.06.001. Epub 2012 Jul 3. No abstract available.
Flegal KM, Kruszon-Moran D, Carroll MD, Fryar CD, Ogden CL. Trends in Obesity Among Adults in the United States, 2005 to 2014. JAMA. 2016 Jun 7;315(21):2284-91. doi: 10.1001/jama.2016.6458.
Witte TN, Enns R. The difficult colonoscopy. Can J Gastroenterol. 2007 Aug;21(8):487-90. doi: 10.1155/2007/520431. No abstract available.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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20078
Identifier Type: -
Identifier Source: org_study_id
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