A proof-of-principle, prospective, randomized, controlled trial demonstrating improved outcomes in scheduled unsedated colonoscopy by the water method - 24/08/11
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 91343Résumé |
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).
Le texte complet de cet article est disponible en PDF.Abbreviations : ITT, OR, RCT, SD, VA
Plan
| 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). |
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| If you would like to chat with one of the authors of this article, you may contact Dr. Leung at [email protected]. |
Vol 72 - N° 4
P. 693-700 - octobre 2010 Retour au numéro
Article précédent
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- Warm water infusion versus air insufflation for unsedated colonoscopy: a randomized, controlled trial
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