Raga 2009.
Methods | Single study centre. Patients were randomly allocated to either the control group (n = 25), or the intervention group (n = 25) according to a computer‐generated sequence. Informed consent was obtained in all cases according to the local ethics committee Power calculation: not done Loss of follow up: there was no loss to follow up and all patients were analysed in the group in which they were allocated |
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Participants | Setting: Tertiary University Teaching Hospital in Spain Inclusion criteria: symptomatic fibroids with uterine size greater or equal to 16 weeks gestation, and a request to retain their uterus Exclusion criteria: history of bleeding disorder, concurrent anticoagulant therapy, a haemoglobin level less than 10g/dl at the time of surgery, and pre‐malignant endometrial histologic findings Mean age: the mean age of patients was 32 years (range 24‐35 years) Ethnicity: not mentioned Myoma: mean number of fibroids per patient was 3.1 in the control and 3.2 in the intervention group. The mean uterine size was 17.9cm in the control group and 18.2cm in the intervention group |
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Interventions | Treatment group: gelatin‐thrombin matrix (Floseal Matrix, Baxter: a substance that activates the clotting process and stops bleeding) was delivered to the site of the uterine bleeding (wound) via a single‐barrel syringe and a special applicator tip according to the manufacturers instruction, before closure Control group: isotonic sodium chloride solution was placed in the uterine bleeding site before closure Diluted vasopressin (1:60) was injected into the myometrium around the myoma and into the myoma tissue in both groups Type of operation: Laparotomy |
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Outcomes | Operative time, blood loss, intraoperative and postoperative complications, and duration of hospital stay | |
Notes | Authors not contacted | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Patients were randomly allocated according to a computer generated sequence |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment is not mentioned |
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 | Isotonic sodium chloride solution as placebo was placed in the uterine bleeding site before closure |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Information on blinding of outcome assessment not provided |