Jaffe 1985.
Methods | Design: randomised placebo‐controlled No. eligible: not stated No. randomised: 98 No. analysed:90 Drop‐outs/withdrawals: 8 (2 for positive preoperative urine culture in treatment group; 3 for positive preoperative urine culture, 2 for malignancy, and 1 for protocol mistake in placebo group) Years of recruitment: not stated Setting: Meir General Hospital, Israel |
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Participants | Inclusion criteria: women admitted for elective abdominal hysterectomy for benign condition Exclusion criteria: antibiotics in previous 2 weeks, allergy to study drugs Age: 46 to 48 years Type of hysterectomy: abdominal | |
Interventions | Treatment 1: 15 mL co‐trimoxazole (antiprotozoal): 12000 mg sulphamethoxazole, 240 mg trimethoprim Control: placebo Route: IV Single/multiple doses: single Timing of doses: infused during last 30 minutes before surgery |
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Outcomes | Urinary tract infection Postoperative fever Adverse effects (narrative data only) Hospital length of stay |
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Funding | Not stated | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | States "randomly assigned" ‐ no other details |
Allocation concealment (selection bias) | Unclear risk | Method not described |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | States that "the placebo group received the placebo with the saline in the same manner"; no details reported on outcome assessor or evaluation of participants |
Incomplete outcome data (attrition bias) All outcomes | High risk | Proportions of withdrawals and reasons for withdrawals not balanced across treatment groups |
Selective reporting (reporting bias) | Low risk | Data available on all prespecified outcomes |
Other bias | Low risk | Baseline demographic characteristics similar between treatment groups |