title: Randomized trial of standard versus magnetic endoscope imaging colonoscopes for unsedated colonoscopy.
abstract: BACKGROUND
  Unsedated colonoscopy has potential benefits, including decreased costs and decreased risks.
  
  
  OBJECTIVE
  To determine whether patient comfort during unsedated colonoscopy can be improved through the use of a magnetic endoscopic imaging (MEI) colonoscope compared with a standard colonoscope.
  
  
  METHODS
  Prospective, patient-blinded, randomized, controlled trial.
  
  
  METHODS
  San Francisco Veterans Affairs Medical Center.
  
  
  METHODS
  Veterans undergoing outpatient screening or surveillance colonoscopy.
  
  
  METHODS
  Use of a standard or MEI colonoscope during unsedated colonoscopy.
  
  
  METHODS
  The primary outcome variable was patient perception of pain using a 7-point scale. The secondary endpoint was patient willingness to undergo a future unsedated colonoscopy.
  
  
  RESULTS
  Of the 160 patients enrolled, 140 completed an unsedated colonoscopy in the study protocol. In a per-protocol analysis, the mean and median pain score was 3.12 (standard deviation 1.22) and 4 (interquartile range 2-4) for the standard colonoscope group and 3.06 (standard deviation 1.13) and 3 (interquartile range 2-4) for the MEI group, where 3 was mild pain (P = not significant). Overall, 80% of subjects were willing to undergo a future unsedated colonoscopy for screening or surveillance. In an intention-to-treat analysis, 80% of subjects (64/80) in the standard colonoscope arm and 79% in the MEI arm (63/80) were willing to undergo a future unsedated colonoscopy (P = not significant).
  
  
  CONCLUSIONS
  Single-center study of mostly male veterans.
  
  
  CONCLUSIONS
  This patient-blinded, randomized, controlled trial did not demonstrate any difference in patient perception of pain or willingness to undergo unsedated examinations when using the MEI versus the conventional colonoscope. Unsedated colonoscopy is generally feasible and well tolerated and is associated with high patient satisfaction rates.
authors.affiliation: Veterans Affairs Medical Center, University of California San Francisco, San Francisco, California, USA.
authors.forename: Amandeep K
authors.initials: AK
authors.lastname: Shergill
authors.forename: Kenneth R
authors.initials: KR
authors.lastname: McQuaid
authors.forename: Arn
authors.initials: A
authors.lastname: Deleon
authors.forename: Michelle
authors.initials: M
authors.lastname: McAnanama
authors.forename: Janak N
authors.initials: JN
authors.lastname: Shah
mesh_terms: D000368:Aged; D016009:Chi-Square Distribution; D020685:Colonoscopes / Q000009:adverse effects; D003113:Colonoscopy / Q000379:methods*; D054810:Deep Sedation; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000209:etiology*; D017060:Patient Satisfaction; D016037:Single-Blind Method; D018709:Statistics, Nonparametric