Boodt 1990.
Methods | Design: randomised double‐blinded No. eligible: not stated No. randomised: 406 No. analysed: 406 (reported in table of results) Drop‐outs/withdrawals: states 7 participants not evaluable (5 underwent vaginal hysterectomy with repair, 2 underwent surgery for urinary incontinence) Years of recruitment: not stated Setting: single centre, Dutch teaching hospital |
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Participants | Inclusion criteria: patients hospitalised for an abdominal or vaginal hysterectomy or a vaginal hysterectomy with vaginal repair, who were informed about the objective of trial in writing before the operation and gave permission to be included Exclusion criteria: emergency operation, known sensitivity to cephalosporins, preexisting infection or antibiotic therapy in the 48 hours preceding surgery Age: 41 to 59 years Type of hysterectomy: abdominal or vaginal (some vaginal with associated procedures). |
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Interventions | Treatment: 1500 mg cefuroxime (second‐generation cephalosporin) plus 500 mg metronidazole (antiprotozoal) Control: placebo Route: IV Single/multiple doses: single Timing of doses: 10‐minute infusion during induction of anaesthesia |
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Outcomes | Urinary tract infection Pelvic infection Postoperative fever Need for therapeutic antibiotics Length of hospital stay Follow up: 6 weeks |
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Funding | Not stated | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Stated as randomised but method not described |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding (performance bias and detection bias) All outcomes | Low risk | "In view of the double blind...both the active and the placebo infusions were coloured yellow..." |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Insufficient information on withdrawals and reasons for withdrawals |
Selective reporting (reporting bias) | Unclear risk | Adverse effects not systematically reported |
Other bias | Low risk | Baseline demographic characteristics similar between treatment groups |