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. 2012 Dec 12;2012(12):CD008211. doi: 10.1002/14651858.CD008211.pub3

Harada 2009.

Methods Generation of allocation sequence: Sealed envelopes
Allocation concealment: Not applicable as not blinded.
Blinding: Not stated but unblinded to endoscopists
Inclusion of all randomised patients: Yes
Participants Number: 592 (391M:201F)
Age: Hood group ‐ 62.6 years +/‐ 63.7. No Hood ‐ 62.7 years +/‐ 64.0 (mean)
Source: A single Japanese tertiary referral centre
Inclusion criteria: Screening/surveillance total colonoscopy.
Exclusion criteria: Emergency, therapeutic or EUS procedures. Poor bowel preparation.
Interventions Colonoscope: PCF‐Q240ZI, PCF‐Q260AI, PCF‐P240AI (Olympus Optical Co, Ltd, Japan).
Bowel Preparation: Colonic lavage with polyethylene glycol.
Intra‐procedure medication: 2‐5mg midazolam as required for pain IV, Scopolamine butyl bromide or glucagon as antispasmodic.
Endoscopists: 3 with >5000 caecal intubations, 1 with >3000 caecal intubations and 2 with <1000 caecal intubations.
Cap: D‐201‐13404, D‐201‐012704, D‐201‐11804 (Olympus Medical Systems, Tokyo, Japan).
Outcomes Included in review: Caecal intubation rate, caecal intubation time, polyp detection rate, Pain during procedure
Excluded from review: Withdrawal time (?sedation/analgesia requirements)
Notes Location: Japan
Source of funding: Not stated
Attempts to clarify information: Not required
Language of Publication: English
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Sealed envelopes.
Allocation concealment (selection bias) High risk Not blinded
Blinding (performance bias and detection bias) 
 All outcomes High risk Not blinded to endoscopist.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All patients included in data analysis.
Selective reporting (reporting bias) Low risk Appropriate outcomes reported.
Other bias Unclear risk Source of funding not stated.