Colonoscopy in the Prone Position for Patients With BMI Greater Than 30
Colonoscopy in the Prone Position for Patients With BMI Greater Than 30 Is Superior to Standard Left Lateral Decubitus Position
In the United States, colonoscopy has become the most commonly used screening test for colorectal cancer. Colonoscopy is typically performed with the patient starting in the left lateral decubitus position, however there is little data to support this practice and starting position is variable amongst individual gastroenterology physicians.
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.
Panoramica dello studio
Descrizione dettagliata
Patients that have been scheduled for colonoscopy will undergo chart review. Patients who meet inclusion criteria will be invited to participate at the time consent is obtained for the colonoscopy. Participants will then be randomized to one of two colonoscopy starting positions.
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Virginia
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Charlottesville, Virginia, Stati Uniti, 22908
- University of Virginia
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- BMI >30
- Undergoing screening or diagnostic colonoscopy with conscious sedation
Exclusion Criteria:
- Pregnant women (self reported).
- 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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Prone Position
Position during colonoscopy
|
Position during colonoscopy
|
|
Comparatore attivo: Left lateral decubitus position
Position during colonoscopy
|
Position during colonoscopy
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Cecal intubation time measured in seconds
Lasso di tempo: Measured once during colonoscopy.
|
Time to advance the colonoscope to the cecum during colonoscopy.
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Measured once during colonoscopy.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Milligrams of sedative used for sedation
Lasso di tempo: Measured once at the completion of the colonoscopy.
|
Amount of fentanyl and midazolam needed for adequate sedation.
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Measured once at the completion of the colonoscopy.
|
|
Technical difficulty of procedure (questionnaire)
Lasso di tempo: Recorded once at the completion of the colonoscopy.
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Measure of subjective sense of difficulty as perceived by the endoscopist.
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Recorded once at the completion of the colonoscopy.
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Brooke Corning, MD, University of Virginia, Dept of Internal Medicine, Divison of Gastroenterology and Hepatology
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- 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.
- Witte TN, Enns R. The difficult colonoscopy. Can J Gastroenterol. 2007 Aug;21(8):487-90. doi: 10.1155/2007/520431. No abstract available.
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Date di iscrizione allo studio
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Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 20078
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