A randomised controlled trial comparing the Cavaterm endometrial ablation system with the Nd:YAG laser for the treatment of dysfunctional uterine bleeding.
OBJECTIVE
To compare the effectiveness of the Cavaterm thermal balloon endometrial ablation system with the Nd:YAG laser for the treatment of dysfunctional uterine bleeding.


METHODS
Randomised controlled trial.


METHODS
Minimal access gynaecological surgery unit in a district general hospital.


METHODS
Seventy-two women with dysfunctional uterine bleeding requesting conservative surgical management of their condition.


METHODS
Women with a normal endometrial biopsy and normal uterine cavity were randomly allocated to endometrial ablation by Cavaterm or Nd:YAG laser. Patients completed pre-operative and 6- and 12-month post-operative questionnaires assessing menstrual symptoms, quality of life, sexual activity and procedural satisfaction and acceptability. All patients received a single dose of gonadotropin-releasing hormone analogue one month pre-operatively and kept blinded to the procedure performed until after the 6-month assessment.


METHODS
The primary outcome measure was amenorrhoea rate. Secondary outcomes were effect on blood loss, quality of life, sexual activity, patient satisfaction and procedure acceptability.


RESULTS
Seventy-two women were randomised. Amenorrhoea rates at 12 months in the Cavaterm and endometrial laser ablation groups were 29% vs 39% (P = 0.286), with combined amenorrhoea and hypomenorrhoea rates of 73% vs 69%, respectively. At 12 months, repeat surgery rates were higher in the endometrial laser ablation group (15% vs 12%, P = 0.395). Cavaterm was an acceptable procedure and 93% of patients satisfied or very satisfied at 12 months (95% endometrial laser ablation). Both treatments were associated with an increase from baseline in the SF-12 physical score (Cavaterm mean difference -3.9, 95% CI -7.9, 0.2, ns; endometrial laser ablation mean difference -5.1, 95% CI -9.5, -0.7, P = 0.003) and mental health score (Cavaterm mean difference -5.6, 95% CI -9.9, -1.3, P = 0.001; endometrial laser ablation mean difference -5.9, 95% CI -11.7, -0.2, P = 0.04). Patient's own assessment of health (EQ-5D VAS) improved from baseline in both groups (Cavaterm mean difference -7.6, 95% CI -13.9, -1.3, P = 0.02; endometrial laser ablation mean difference -5.4, 95% CI -14.9, 4.2, ns). EQ-5D index scores also improved (Cavaterm mean difference -0.06, 95% CI -0.2, 0.005, ns; endometrial laser ablation mean difference -0.17, 95% CI -0.3, -0.02, P = 0.02). There were no major complications in either group.


CONCLUSIONS
The results with the Cavaterm thermal balloon endometrial ablation system are as good as those obtained with the Nd:YAG laser when used for the treatment of dysfunctional uterine bleeding in the short term. It results in a significant reduction in menstrual blood loss, patient satisfaction and improvement in patient quality of life. Larger studies with longer follow up are required to determine its place in the modern treatment of dysfunctional uterine bleeding.
Hawe
Jed
J
Department of Obstetrics and Gynaecology, Countess of Chester Hospital, UK.
Abbott
Jason
J
Hunter
David
D
Phillips
Graham
G
Garry
Ray
R
D000328:Adult; D000700:Analgesics / Q000627:therapeutic use; D004717:Endometrium / Q000601:surgery*; D005260:Female; D006801:Humans; D017075:Laser Coagulation / Q000379:methods*; D008595:Menorrhagia / Q000601:surgery*; D008598:Menstruation / Q000502:physiology; D008875:Middle Aged; D010149:Postoperative Pain / Q000209:etiology / Q000517:prevention & control; D010342:Patient Acceptance of Health Care; D011446:Prospective Studies; D011788:Quality of Life; D012008:Recurrence; D012086:Reoperation; D012725:Sexual Behavior; D016896:Treatment Outcome
D000700:Analgesics