Celik 2003.
Methods | Single centre study Described as randomised, but no details on how patients were allocated to trial interventions Both patients, care providers, and outcome assessors were blinded to treatment allocation Power calculation: performed No losses to follow up, and all patients were analysed in groups to which they were assigned Source of funding: not mentioned |
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Participants | Setting: university hospital, Elazig, Turkey Inclusion criteria: symptomatic uterine fibroids scheduled for myomectomy n = 25 Mean age: 31.7 years (SD 4.4) in the treatment arm and 32.2 years (SD 2.9) in the placebo group Ethnicity: not mentioned | |
Interventions | Treatment arm (n = 13): 400 uG misoprostol administered vaginally 1 hour before surgery Control arm (n = 12): placebo of identical shape and colour Sizes of fibroids: mean diameter of myomas 150.7 mm (SD 28.6) in the treatment arm and 154.2 mm (SD 24.7) in the control arm Type of operation: laparotomy | |
Outcomes | Perioperative blood loss, postoperative haemoglobin, operation time, blood transfusion, hospital stay, and postoperative morbidity Blood loss determined by aspiration equipment during the operation |
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Notes | Indication for myomectomy: symptomatic uterine fibroid Authors not contacted |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as randomised, but no details on how patients were allocated to trial interventions |
Allocation concealment (selection bias) | Unclear risk | Unclear |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No incomplete outcome data |
Selective reporting (reporting bias) | Unclear risk | We do not have access to the study protocol |
Other bias | Low risk | No other sources of bias identified |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Both participants and personnel were blinded to treatment allocation |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors were blinded to treatment allocation |