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. 2014 Aug 15;2014(8):CD005355. doi: 10.1002/14651858.CD005355.pub5

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
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
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
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