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

Felix W. Leung, Judith O. Harker, Guy Jackson, Kate E. Okamoto, Omid M. Behbahani, Nora J. Jamgotchian, H. Steven Aharonian, Paul H. Guth, Surinder K Mann, Joseph Leung

Research output: Contribution to journalArticle

82 Citations (Scopus)

Abstract

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).

Original languageEnglish (US)
Pages (from-to)693-700
Number of pages8
JournalGastrointestinal Endoscopy
Volume72
Issue number4
DOIs
StatePublished - Oct 2010

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Colonoscopy
Randomized Controlled Trials
Water
Intubation
Veterans
Air
Insufflation
Nonparametric Statistics
Ambulatory Care Facilities
Adenoma
Observational Studies
Odds Ratio
Clinical Trials
Students

ASJC Scopus subject areas

  • Gastroenterology
  • Radiology Nuclear Medicine and imaging

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A proof-of-principle, prospective, randomized, controlled trial demonstrating improved outcomes in scheduled unsedated colonoscopy by the water method. / Leung, Felix W.; Harker, Judith O.; Jackson, Guy; Okamoto, Kate E.; Behbahani, Omid M.; Jamgotchian, Nora J.; Aharonian, H. Steven; Guth, Paul H.; Mann, Surinder K; Leung, Joseph.

In: Gastrointestinal Endoscopy, Vol. 72, No. 4, 10.2010, p. 693-700.

Research output: Contribution to journalArticle

Leung, Felix W. ; Harker, Judith O. ; Jackson, Guy ; Okamoto, Kate E. ; Behbahani, Omid M. ; Jamgotchian, Nora J. ; Aharonian, H. Steven ; Guth, Paul H. ; Mann, Surinder K ; Leung, Joseph. / A proof-of-principle, prospective, randomized, controlled trial demonstrating improved outcomes in scheduled unsedated colonoscopy by the water method. In: Gastrointestinal Endoscopy. 2010 ; Vol. 72, No. 4. pp. 693-700.
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AU - Okamoto, Kate E.

AU - Behbahani, Omid M.

AU - Jamgotchian, Nora J.

AU - Aharonian, H. Steven

AU - Guth, Paul H.

AU - Mann, Surinder K

AU - Leung, Joseph

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N2 - 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).

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