Taylor 2005.
Methods | Two centre study Allocation by sealed sequentially numbered opaque envelopes containing computer‐generated random numbers Patients blinded but care providers not blinded 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 | |
Participants | Setting: two university hospitals, London, UK Inclusion criteria: symptomatic fibroids, uterine size at least 14 weeks, and patient request for myomectomy Exclusion criteria: history of bleeding disorder, concurrent anti‐coagulant therapy, haemoglobin less than 10.5g/dl at the time of surgery, pre‐malignant endometrial histology n = 28 Mean age: 39.5 years (SD 4.7) in control arm and 42.6 years (SD 6.7) in treatment arm Ethnicity: not described Number of fibroids: range 1‐34 | |
Interventions | Treatment arm (n = 14): a number one polyglactin suture tied around the cervix to occlude uterine artery and left there after surgery, plus a polythene tourniquet tied round the infundibulopelvic ligament and removed after the operation Control arm (n = 14): no treatment added to the normal myomectomy procedure Type of operation: laparotomy | |
Outcomes | Perioperative blood loss, need for blood transfusion, operative morbidity Blood loss was assessed by weighing swabs and measuring blood collected by suction | |
Notes | Indications for myomectomy: symptomatic uterine fibroids Preoperative GnRH agonists prescribed to anaemic patients to increase preoperative haemoglobin to more than 10.5g/dl Authors contacted July 2015 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Allocation by sealed sequentially‐numbered opaque envelopes containing 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 | High risk | Statistically significant difference in mean age of the two groups |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Patients blinded but care providers not blinded |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Unclear if outcome assessment blinded |