Cook 1990.
Methods | Design: double‐blind, prospective randomized controlled trial Country: England Multisite: no International: no Treatment duration: preoperative period Follow‐up: 3 days postoperatively Operative procedure(s): ambulatory laparoscopy Randomization unit: participants Analysis unit: individual | |
Participants |
Exclusion criteria included:
Randomized to:
Two participants were apparently randomized but not included in the results. No reason for exclusion was given. Main characteristics of participants:
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Interventions |
Co‐interventions: none stated |
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Outcomes |
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Notes | Trial registration: not stated Funder: not stated A priori sample size estimation: not stated Conducted: dates not stated Declared conflicts of interest: not stated | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Paper states (quote) "each patient was allocated at random" but no further information on methodology provided. |
Allocation concealment (selection bias) | Unclear risk | Paper states (quote) "each patient was allocated at random" but no further information on methodology provided. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Infusion bags were hidden to prevent unblinding, but it was not specified how this applied to the (quote) "no preoperative fluid" group. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessments were made by an author blinded to treatment groups. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Two patients were not assessed. Material impact questionable as this represents a small fraction of the participants but no explanation was given. |
Selective reporting (reporting bias) | Unclear risk | All outcomes were reported. An intention‐to‐treat analysis was not completed. |
Other bias | Low risk | There were no other sources of bias. |