Skip to main content
. 2019 Jan 22;2019(1):CD001501. doi: 10.1002/14651858.CD001501.pub5

Hawe 2003.

Methods Single‐centre study, randomised controlled trial
Timing: recruited between August 1997 and April 2000
Participants 72 women randomised; aged 29 to 51 years (mean cav 41.4, mean laser 41.1); recruited from a minimal access gynaecological surgery unit at a district general hospital
 Inclusion criteria:

  • Normal endometrial biopsy

  • No intrauterine pathology

  • Normal uterine cavity (uterine length < 12 cm)

  • High on blood loss score (> 100)

  • Normal cervical cytology

  • Completed family and using contraception


Exclusion criteria:

  • Endometrial hyperplasia and malignancy

  • Active pelvic infection

  • Intrauterine pathology
Interventions

  • Cavatern thermal balloon endometrial ablation (n = 37)

  • Nd:YAG laser (n = 35)


Duration: preop 6 and 12 months for questionnaire; pictorial blood loss assessment 6 months
Outcomes Primary
• Amenorrhoea rate, then effect on menstrual status
• Questionnaire assessing menstrual symptoms
• QOL
• Sexual activity
• Procedure satisfaction and acceptability ‐ included questionnaires EQ‐5D, SF‐12, SAQ; VAS; pain VAS
• Operative details and morbidity
Notes Power calculation performed; study authors did not report intention‐to‐treat analysis
 Funding: not reported but Wallsten Medical, which supplied the Cavaterm equipment
Conflicts of interest: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random permutated blocks predetermined by computer‐generated random number tables (blocks of 4 sequentially numbered envelopes)
Allocation concealment (selection bias) Low risk Sequentially numbered envelopes
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Participants, nursing staff, and GP blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Assessor of outcomes blinded
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 1 participant excluded after randomisation because she did not meet inclusion criteria; 4 other participants lost by 12 months ‐ unlikely to affect assessment of outcomes
Selective reporting (reporting bias) Low risk All prespecified outcomes reported
Other bias Unclear risk Groups appeared balanced at baseline except for cavity length, but differences unlikely to be clinically significant; a medical equipment company provided one of the interventions