Benassi 2000.
Methods | Single centre study Allocation to interventions using computer‐generated random numbers Patients blinded, but assessors unblinded Power calculation: not done No losses to follow up, and all patients were analysed in groups to which they were assigned Source of funding: not mentioned | |
Participants | Setting: university hospital, Parma, Italy Inclusion criteria: patients with symptomatic fibroids (menorrhagia, pelvic pain, and compression) Exclusion criteria: use of hormonal substances within 6 months proceeding myomectomy, previous uterine surgery, pelvic inflammatory diseases n = 58 Age range: 25‐45 years Ethnicity not described Size of myomas: 2‐17 cm | |
Interventions | Treatment group (n = 29): use of sodium‐2‐mercaptoethane sulfonate (mesna) for chemical dissection (removal of fibroids with the aid of a chemical substance that breaks down tissues) of myoma during myomectomy Control group (n = 29): use of saline for dissection of myomas Type of operation: laparotomy | |
Outcomes | Postoperative haemoglobin and haematocrit, duration of operation, hospital stay, and postoperative complications | |
Notes | Indications for myomectomy: menorrhagia, pelvic pain, and compression Authors not contacted |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Allocation to interventions using computer‐generated random numbers |
Allocation concealment (selection bias) | Low risk | Adequate |
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 | Patients blinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Outcome assessors unblinded |