Pinion 1994.
Study characteristics | ||
Methods | Randomisation, ratio of 2:1:1 (hysterectomy:resection:ablation), by a series of numbered opaque envelopes in a random order Single‐centre, parallel‐group, no blinding Setting: general gynaecology clinic of the Aberdeen Royal Infirmary in Scotland, UK Number of participants randomly assigned: 204 Number of withdrawals: 6 (2 before surgery and 4 refused the allocated treatment) Power calculation for sample size performed and analysis by intention to treat |
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Participants | Women with mean age 40 years, eligible to undergo hysterectomy for menorrhagia Inclusion criteria: aged < 50 years; weight < 100 kg; clinical diagnosis of dysfunctional uterine bleeding; uterus < 10 weeks of gestational size; normal endometrial histology Exclusion criteria: none reported |
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Interventions | Treatment 1: laser ablation (1st generation) (53 women) or endometrial resection (TCRE). Women received gonadotrophin releasing hormone
agonist analogue (Goserelin) five weeks preoperatively (52 women) Treatment 2: hysterectomy (abdominal (87 women), vaginal (12 women) Duration: 4 years' follow‐up Prior experience of the surgeon not mentioned |
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Outcomes |
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Notes | Author contacted for additional data but no reply received. This trial has 4 publications using the same study population and assessing different outcomes. Data usually available only for the laser ablation and endometrial resection combined. Source of funding: Scottish Office Home and Health Dept and ICI (Zeneca) No information stated regarding trial registration |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation sequence not described. |
Allocation concealment (selection bias) | Low risk | Series of numbered opaque envelopes. |
Blinding (performance bias and detection bias) All outcomes | High risk | Not feasible for a comparison of surgical techniques. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Dropouts minimal and unlikely to cause bias. |
Selective reporting (reporting bias) | Unclear risk | No prior protocol identified. |
Other bias | Unclear risk | Groups appeared balanced at baseline. Surgeons' previous experience was not reported. |