Vincelette 1983.
| Methods | Design: randomised double‐blinded No. eligible: 197 abdominal, 49 vaginal No. randomised: 108 abdominal (89 declined to take part), ? 38 vaginal (11 refused to take part) No. analysed: 106 abdominal, 38 vaginal Drop‐outs/withdrawals: 2 (1 in each abdominal group: 1 did not have hysterectomy, 1 had incorrect drug protocol) Years of recruitment: not stated Setting: Montreal General Hospital, Canada |
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| Participants | Inclusion criteria: women consecutively admitted for elective abdominal hysterectomy Exclusion criteria: thyroid disease, antibiotics in past 2 weeks, pelvic inflammatory disease, pregnancy, physician preference for prophylaxis Age: mean 42 to 44 years Type of hysterectomy: abdominal or vaginal | |
| Interventions | Treatment: 500 mg metronidazole (antiprotozoal) Control: placebo Route: IV Single/multiple doses: multiple Timing of doses: first dose on call to operating theatre, second and third doses at 6‐hourly intervals |
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| Outcomes | Abdominal wound infection Urinary tract infection Pelvic infection Other serious infection Postoperative fever Adverse effects Need for therapeutic antibiotics Hospital length of stay Follow‐up: 6 weeks |
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| Funding | Medical Research Council of Canada and Rhône‐Poulenc Pharma Inc | |
| Notes | 4 had neoplasm ‐ may or may not be cervical intraepithelial neoplasia | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Study was reported as "randomly assigned" ‐ no additional details |
| Allocation concealment (selection bias) | Unclear risk | Method not stated |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | States that "a double‐blind clinical evaluation was performed." No information on outcome assessor reported |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Total withdrawals constitute a small fraction of participants randomised (2%) |
| Selective reporting (reporting bias) | Low risk | Data available on all prespecified outcomes |
| Other bias | Low risk | Baseline demographic characteristics similar between treatment groups |
ITT: intention‐to‐treat
LOS: length of stay
SD: standard deviation