Chongsomchai 2002.
Methods | Design: randomised double‐blinded No. eligible: 330 No. randomised: 330 No. analysed: 321 Drop‐outs/withdrawals: 9 did not undergo hysterectomy as planned (3 in cefazolin group, 4 in ampicillin group, 2 in placebo group) Years of recruitment: 1997 to 1999 Setting: 2 regional hospitals in Thailand |
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Participants | Inclusion criteria: scheduled for elective total abdominal hysterectomy Exclusion criteria: preoperative fever or infection, allergic to ampicillin or cefazolin, had received antibiotics within 48 hours of surgery, emergency cases, pregnancy‐related cases Age: mean 43 years Type of hysterectomy: abdominal | |
Interventions | Treatment 1: 1 gram ampicillin (penicillin) Treatment 2: 1 gram cefazolin (first‐generation cephalosporin) Control: placebo Route: IV Single/multiple doses: single Timing of doses: 30 minutes before surgery |
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Outcomes | Postoperative infection, early and late Abdominal wound infection Urinary tract infection Pelvic infection Adverse effects (narrative data only) Other serious infection Postoperative fever Asymptomatic infection Follow‐up: 4 weeks |
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Funding | National Research Council, Thailand | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Computer‐generated randomization" |
Allocation concealment (selection bias) | Low risk | "Opaque sealed envelopes" ‐ probably done |
Blinding (performance bias and detection bias) All outcomes | Low risk | "Patients, their gynaecologists, all investigators and evaluators were blinded to the random allocation throughout the study" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Proportions of withdrawals/losses to follow‐up similar in treatment groups and < 10% in each group |
Selective reporting (reporting bias) | Low risk | All reported outcomes were prespecified in the methods section |
Other bias | Low risk | Baseline demographic characteristics similar between treatment groups |