Sinha 2005.
Methods | Single centre study Allocation by computer‐generated random numbers Unblinded Power calculation: not performed 8.3% (4/48) patients excluded because of difficulties which led to them receiving the treatment of the intervention arm and not the control arm as randomised Intention‐to‐treat analysis: not performed Source of funding: not mentioned | |
Participants | Setting: private endoscopy centre, Mumbai, India
Inclusion criteria: uterus larger than 12 weeks on bimanual examination, ultrasound confirmation of presence of at least one myoma 7 cm or greater and/or presence of three or more myomas greater than 5 cm in size Exclusion criteria: submucosal myoma, associated ovarian lesions or other pathology discovered by ultrasound exam, a history of surgery n = 48 Mean age: 32.95 years (SD 4.65) in treatment arm and 33.8 years (SD 6.35) in control arm Ethnicity: not described Sizes of myomas: the mean size of the myoma was 7.6 cm (SD 4.2) in treatment arm and 7.6 cm (SD 4. 5) in the control arm |
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Interventions | Treatment arm (n = 24): enucleation of myoma by morcellation while still attached to uterus Control arm (n = 20): conventional technique of complete enucleation followed by morcellation Type of operation: laparoscopy | |
Outcomes | Perioperative blood loss, hospital stay, and length of surgery Perioperative blood loss estimated by consistently sucking the blood into a suction bottle without any irrigation until the intracorporeal suturing was completed and the haemostasis confirmed | |
Notes | Indications for myomectomy: symptomatic myomas Authors not contacted |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Allocation by computer‐generated random numbers |
Allocation concealment (selection bias) | Low risk | Adequate |
Incomplete outcome data (attrition bias) All outcomes | High risk | 8.3% (4/48) patients excluded because of difficulties which led to them receiving the treatment of the intervention arm and not the control arm as randomised. |
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 | High risk | Unblinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Unblinded |