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. 2019 Jan 22;2019(1):CD001501. doi: 10.1002/14651858.CD001501.pub5

Bhattacharya 1997.

Methods Single‐centre parallel randomised controlled trial (Scotland)
Participants 372 women; mean age 41 years
 Inclusion criteria:
  • ≤ 50 years of age

  • < 100 kg in weight

  • Clinical diagnosis of dysfunctional uterine bleeding

  • Uterus < size of at pregnancy at 10 weeks and normal endometrial histology


Exclusion criteria: not reported
Setting: gynaecology clinics at Aberdeen Royal Infirmary, Scotland
Timing: not reported
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
Outcomes Outcomes
Operative complications:
  • Postoperative recovery

  • Relief of menstrual and other symptoms

  • Need for further surgical treatment

  • Satisfaction with treatment

  • Differential resource use

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
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