Endometrial resection and ablation techniques for heavy menstrual bleeding.
Avainsanat
Abstrakti
BACKGROUND
Heavy menstrual bleeding (HMB) is a significant health problem in premenopausal women; it can reduce their quality of life and cause anaemia. First-line therapy has traditionally been medical therapy but this is frequently ineffective. On the other hand, hysterectomy is obviously 100% effective in stopping bleeding but is more costly and can cause severe complications. Endometrial ablation is less invasive and preserves the uterus, although long-term studies have found that the costs of ablative surgery approach the cost of hysterectomy due to the requirement for repeat procedures. A large number of techniques have been developed to 'ablate' (remove) the lining of the endometrium. The gold standard techniques (laser, transcervical resection of the endometrium and rollerball) require visualisation of the uterus with a hysteroscope and, although safe, require skilled surgeons. A number of newer techniques have recently been developed, most of which are less time consuming. However, hysteroscopy may still be required as part of the ablative techniques and some of these techniques must be considered to be still under development, requiring refinement and investigation.
OBJECTIVE
To compare the efficacy, safety and acceptability of of endometrial destruction techniques to reduce heavy menstrual bleeding (HMB) in premenopausal women.
METHODS
We searched the Cochrane Menstrual Disorders and Subfertility Group Specialised Register of controlled trials, Cochrane Central Register of Controlled Trials CENTRAL), MEDLINE, EMBASE, CINAHL, and PsycInfo, (from inception to June 2013). We also searched trials registers, other sources of unpublished or grey literature and reference lists of retrieved studies, and made contact with experts in the field and pharmaceutical companies that manufacture ablation devices.
METHODS
Randomised controlled trials (RCTs) comparing different endometrial ablation techniques in women with a complaint of HMB without uterine pathology were eligible. The outcomes included reduction of HMB, improvement in quality of life, operative outcomes, satisfaction with the outcome, complications and need for further surgery or hysterectomy.
METHODS
Two review authors independently selected trials for inclusion, assessed trials for risk of bias and extracted data. Attempts were made to contact authors for clarification of data in some trials. Adverse events were only assessed if they were separately measured in the included trials. Comparisons were made with individual techniques and an overall comparison between first and second-generation ablation methods was also undertaken.
RESULTS
Twenty five trials (4040 women) with sample sizes ranging from 20 to 372 were included in the review. A majority of the trials had a specified method of randomisation, adequate description of dropouts and no evidence of selective reporting. Less than half had adequate allocation concealment and most were unblinded.There was insufficient evidence to suggest superiority of a particular technique in the pairwise comparisons between individual ablation and resection methods.In the overall comparison of the newer 'blind' techniques (second-generation) with the gold standard hysteroscopic ablative techniques (first-generation) there was no evidence of overall differences in the improvement in HMB (12 RCTs) or patient satisfaction (11 RCTs).Surgery was an average of 15 minutes shorter (mean difference (MD) 14.9, 95% CI 10.1 to 19.7, 9 RCTs; low quality evidence), local anaesthesia was more likely to be employed (relative risk (RR) 2.8, 95% CI 1.8 to 4.4, 6 RCTs; low quality evidence) and equipment failure was more likely (RR 4.3, 95% CI 1.5 to 12.4, 3 RCTs; moderate quality evidence) with second-generation ablation. Women undergoing newer (second-generation) ablative procedures were less likely to have fluid overload, uterine perforation, cervical lacerations and hematometra than women undergoing the more traditional type of ablation and resection techniques (RR 0.18, 95% CI 0.04 to 0.79, 4 RCTs; RR 0.32, 95% CI 0.1 to 1.0, 8 RCTs; RR 0.22, 95% CI 0.08 to 0.61, 8 RCTs; and RR 0.32, 95% CI 0.12 to 0.85, 5 RCTs; all moderate quality evidence, respectively). However, women were more likely to have nausea and vomiting and uterine cramping (RR 2.0, 95% CI 1.3 to 3.0, 4 RCTs; and RR 1.2, 95% CI 1.0 to 1.4, 2 RCTs; both moderate quality evidence, respectively). The risk of requiring either further surgery of any kind or hysterectomy specifically was reduced with second-generation ablative methods compared to first-generation ablation up to 10 years after surgery (RR 0.69, 95% CI 0.48 to 0.99, 1 RCT; and RR 0.60, 95% CI 0.38 to 0.96, 1 RCT; both moderate quality evidence, respectively) but not at earlier follow up. Additional research is required to confirm this finding.
CONCLUSIONS
Endometrial ablation techniques offer a less invasive surgical alternative to hysterectomy. The rapid development of a number of new methods of endometrial destruction has made systematic comparisons between individual methods and with the 'gold standard' first-generation techniques difficult. Most of the newer techniques are technically easier to perform than traditional hysteroscopy-based methods but technical difficulties with the new equipment need to be addressed. Overall, the existing evidence suggests that success, satisfaction rates and complication profiles of newer techniques of ablation compare favourably with hysteroscopic techniques.