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A proof-of-principle, prospective, randomized, controlled trial demonstrating improved outcomes in scheduled unsedated colonoscopy by the water method - 24/08/11

Doi : 10.1016/j.gie.2010.05.020 
Felix W. Leung, MD , Judith O. Harker, PhD, Guy Jackson, LVN, Kate E. Okamoto, LVN, Omid M. Behbahani, MD, Nora J. Jamgotchian, MS, H. Steven Aharonian, MD, Paul H. Guth, MD, Surinder K. Mann, MD, Joseph W. Leung, MD
Current affiliations: Research and Medical Services (F.W.L., J.O.H., G.J., K.E.O., O.M.B., N.J.J., H.S.A., P.H.G.), Sepulveda Ambulatory Care Center, Veterans Affairs Greater Los Angeles Healthcare System, North Hills, California, David Geffen School of Medicine at UCLA (F.W.L., H.S.A., P.H.G.), Los Angeles, California, Sacramento VAMC (S.K.M., J.W.L.), Veterans Affairs Northern California Healthcare System, Mather, California, UC Davis Medical Center (S.K.M., J.W.L.), Sacramento, California 

Reprint requests: Felix W. Leung, MD, FACG, Division of Gastroenterology (111G), David Geffen School of Medicine at UCLA, Sepulveda Ambulatory Care Center, Veterans Affairs Greater Los Angeles Healthcare System, 16111 Plummer Street, North Hills, CA 91343

Resumen

Background

An observational study in veterans showed that a novel water method (water infusion in lieu of air insufflation) enhanced cecal intubation and willingness to undergo a repeat scheduled unsedated colonoscopy.

Objective

To confirm these beneficial effects and significant attenuation of discomfort in a randomized, controlled trial (RCT).

Design

Prospective RCT, intent-to-treat analysis.

Setting

Veterans Affairs ambulatory care facility.

Patients

Veterans undergoing scheduled unsedated colonoscopy.

Interventions

During insertion, the water and traditional air methods were compared.

Main Outcome Measurements

Discomfort and procedure-related outcomes.

Results

Eighty-two veterans were randomized to the air (n = 40) or water (n = 42) method. Cecal intubation (78% vs 98%) and willingness to repeat (78% vs 93%) were significantly better with the water method (P < .05; Fisher exact test). The mean (standard deviation) of maximum discomfort (0 = none, 10 = most severe) during colonoscopy was 5.5 (3.0) versus 3.6 (2.1) P = .002 (Student t test), and the median overall discomfort after colonoscopy was 3 versus 2, P = .052 (Mann-Whitney U test), respectively. The method, but not patient characteristics, was a predictor of discomfort (t = −1.998, P = .049, R2 = 0.074). The odds ratio for failed cecal intubation was 2.09 (95% CI, 1.49-2.93) for the air group. Fair/poor previous experience increased the risk of failed cecal intubation in the air group only. The water method numerically increased adenoma yield.

Limitations

Single site, small number of elderly men, unblinded examiner, possibility of unblinded subjects, restricted generalizability.

Conclusions

The RCT data confirmed that the water method significantly enhanced cecal intubation and willingness to undergo a repeat colonoscopy. The decrease in maximum discomfort was significant; the decrease in overall discomfort approached significance. The method, but not patient characteristics, was a predictor of discomfort. (Clinical trial registration number NCT00747084).

El texto completo de este artículo está disponible en PDF.

Abbreviations : ITT, OR, RCT, SD, VA


Esquema


 DISCLOSURE: The following author disclosed a financial relationship relevant to this publication: Dr. F.W. Leung: member of the Advisory Board of Invendo. The other authors disclosed no financial relationships relevant to this publication. Supported in part by ACG Clinical Research Award (F.W.L., 2009), the ASGE Career Development Award (F.W.L., 1985), and VA Clinical Merit Research Funds (F.W.L., 2006-2009).
 If you would like to chat with one of the authors of this article, you may contact Dr. Leung at felix.leung@va.gov.


© 2010  American Society for Gastrointestinal Endoscopy. Publicado por Elsevier Masson SAS. Todos los derechos reservados.
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Vol 72 - N° 4

P. 693-700 - octobre 2010 Regresar al número
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  • Comprehensive validation of the Boston Bowel Preparation Scale
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  • Warm water infusion versus air insufflation for unsedated colonoscopy: a randomized, controlled trial
  • Franco Radaelli, Silvia Paggi, Arnaldo Amato, Vittorio Terruzzi

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