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

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, R(2) = 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).

Impact of a novel water method on scheduled unsedated colonoscopy in U.S. veterans.

BACKGROUND: Intermittent warm-water infusion in lieu of air insufflation permitted 52% of patients who accepted sedation on demand to complete colonoscopy without sedation. OBJECTIVE: To test the hypothesis that the water method enhances cecal intubation and increases the proportion of patients who report willingness to repeat a scheduled unsedated colonoscopy. DESIGN: Observational study. PATIENTS: Two consecutive groups of veterans. INTERVENTIONS: From June 2005 to May 2006, the usual air insufflation method was used to aid colonoscope insertion. From June 2006 to October 2007, the water method was used. MAIN OUTCOME MEASUREMENTS: Cecal intubation; report of willingness to repeat unsedated colonoscopy. RESULTS: Sixty-two and 63 veterans were examined by the air method and the water method, respectively. Intention-to-treat analysis revealed that the cecal intubation rate with the water method (97% [61/63]) was significantly higher than that with the air method (76% [47/62]). The proportion of patients who reported willingness to repeat unsedated colonoscopy was significantly higher with the water method (90% [57/63]) compared with the air method (69% [43/62]). LIMITATIONS: Single site, nonrandomized, unblinded, small number of elderly male veterans. CONCLUSION: The effects of the water method in the group for scheduled unsedated colonoscopy were sufficiently provocative to warrant calling for their confirmation by a randomized controlled trial.

Involvement of trainees in routine unsedated colonoscopy: review of a pilot experience.

BACKGROUND: Unsedated colonoscopy is not required by the Accreditation Council of Graduate Medical Education in the curriculum of GI trainees. OBJECTIVE: We describe our pilot experience with trainee participation in unsedated colonoscopy. DESIGN: A retrospective review of a performance improvement program to provide access to colonoscopy. SETTING: A Veteran's Affair ambulatory care facility that discontinued sedated colonoscopy because of a nursing shortage. PATIENTS: A total of 145 of 483 patients who chose unsedated colonoscopy after both sedated and unsedated options were discussed. INTERVENTIONS: GI fellows performed unsedated colonoscopy under the supervision of the attending physician. MAIN OUTCOME MEASUREMENTS: Cecal intubation rate, patient assessment of the reasons for the choice, the unsedated experience, willingness to have another colonoscopy, and the rate of return for unsedated colonoscopy among eligible patients. RESULTS: Cecal intubation was achieved in 112 of 145 patients. The adjusted success rate (excluding inadequate bowel preparation and an obstructing lesion) was 81%. The most frequently acknowledged reason for the choice was the ability to communicate with the colonoscopist. Eighty-six patients reported a good experience and were likely to accept another unsedated colonoscopy. To date, all 8 patients eligible for 3-year follow-up successfully completed another unsedated examination. LIMITATION: An uncontrolled, nonrandomized review in predominantly male older veterans. CONCLUSIONS: An unsedated colonoscopy might be acceptable to some populations, particularly when communication with clinicians and procedural convenience are highly valued. Involvement of trainees is feasible. Randomized controlled comparisons of sedated and unsedated options in terms of safety (eg, sedation and procedure-related complications) and cost in settings with and without a nursing shortage deserve to be considered.