Kauer 1990.
Methods | Design: randomised double‐blinded No. eligible: 100 No. randomised: 78 No. analysed: 68 Drop‐outs/withdrawals: 10 (2 in treatment group 1, 4 in each of treatment groups 2 and 3: 5 had asymptomatic bacteriuria, 3 were given an incorrect antibiotic, 2 had abdominal not vaginal surgery) Years of recruitment: not reported Setting: Roman Catholic Hospital, Groningen, The Netherlands |
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Participants | Inclusion criteria: women ≥ 20 years of age having vaginal hysterectomy Exclusion criteria: allergy to study drugs, antibiotics within 48 hours of surgery, preexisting infection Age: mean 55 to 60 years Type of hysterectomy: vaginal | |
Interventions | Treatment 1: 1500 mg cefuroxime (second‐generation cephalosporin) Treatment 2: 500 mg metronidazole (antiprotozoal) Treatment 3: 1500 mg cefuroxime + 500 mg metronidazole Route: IV Single/multiple doses: single Timing of doses: 15 minutes preoperatively |
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Outcomes | Postoperative infection, early Urinary tract infection Pelvic infection Need for therapeutic antibiotics Adverse effects (narrative data only) Hospital length of stay Follow‐up: duration not clearly stated |
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Funding | Not stated | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | States that sequence was generated through "table of random numbers" |
Allocation concealment (selection bias) | Low risk | States that "patients were assigned by the hospital pharmacist..." |
Blinding (performance bias and detection bias) All outcomes | Low risk | States "vial and colour of the solution being indistinguishable...the observer was unaware of the antibiotics used..." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Proportions of withdrawals and reasons for withdrawals fairly balanced across treatment groups |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to make a conclusive judgement |
Other bias | Low risk | Baseline demographic characteristics similar between treatment groups |