Bhattacharya 1997.
Methods | Single‐centre parallel randomised controlled trial (Scotland) | |
Participants | 372 women; mean age 41 years
Inclusion criteria:
Exclusion criteria: not reported Setting: gynaecology clinics at Aberdeen Royal Infirmary, Scotland Timing: not reported |
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Interventions | All women underwent clinical assessment and endometrial biopsy before treatment, as well as endometrial preparation with a single injection of goserelin 3.6 mg subcutaneously 5 weeks before surgery
Laser ablation (n = 188)
vs TCRE with rollerball (n = 184) Duration: 12 months |
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Outcomes |
Outcomes Operative complications:
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Notes | Recruitment of participants took place over 2 different time periods. 105 women were randomised to ELA or TCRE for an earlier study. After a gap of 8 months, an additional 267 women were recruited Power calculation was performed for sample size, and study authors reported intention‐to‐treat analysis (although because of dropouts, this was impossible) Source of funding: Chief Scientist Office at the Scottish Department of Health Conflicts of interest: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer generated |
Allocation concealment (selection bias) | Low risk | Numbered sealed opaque envelopes stratified per consultant |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open study |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Open study |
Incomplete outcome data (attrition bias) All outcomes | High risk | Different numbers of participants provided data for different outcomes; 366/372 for operative details, 321/372 for satisfaction, 306/372 for menstrual loss |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes reported |
Other bias | Unclear risk | Recruitment of participants over 2 different time periods, and the 2 groups differed in baseline characteristics. 15% of one group crossed over to the other treatment, but analyses were undertaken according to randomised group |