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 |
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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. |
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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). |
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Outcomes | Included in review: Caecal intubation rate, caecal intubation time, polyp detection rate, Pain during procedure Excluded from review: Withdrawal time (?sedation/analgesia requirements) |
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Notes | Location: Japan Source of funding: Not stated Attempts to clarify information: Not required Language of Publication: English |
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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. |