HEALTH for heavy menstrual bleeding: real-world implications

Heavy menstrual bleeding is common and can substantially affect quality of life.1Liu Z Doan QV Blumenthal P Dubois RW A systematic review evaluating health-related quality of life, work impairment, and health-care costs and utilization in abnormal uterine bleeding.Value Health. 2007; 10: 183-194Summary Full Text PDF PubMed Scopus (180) Google Scholar Millions of women worldwide defer personal, professional, and family goals because of heavy menstrual bleeding. In The Lancet, Kevin Cooper and colleagues2Cooper K Breeman S Scott NW et al.Laparoscopic supracervical hysterectomy versus endometrial ablation for women with heavy menstrual bleeding (HEALTH): a parallel-group, open-label, randomised controlled trial.Lancet. 2019; (published online Sept 12.)http://dx.doi.org/10.1016/S0140-6736(19)31790-8Summary Full Text Full Text PDF Scopus (10) Google Scholar report a multicentre, parallel-group, open-label randomised trial of 660 women younger than 50 years that compared laparoscopic supracervical hysterectomy with endometrial ablation for the management of heavy menstrual bleeding. To our knowledge, the HEALTH trial is one of the largest randomised controlled trials to date in benign gynaecology. Society guidelines describe hysterectomy as a last resort in the context of providing less invasive options for gynaecological conditions.3NICEHeavy menstrual bleeding: assessment and management.https://www.nice.org.uk/guidance/ng88Date: 2018Google Scholar However, methodologically sound evaluation is required to test the status quo. The HEALTH trial found that at 15 months after randomisation, women allocated laparoscopic supracervical hysterectomy were more satisfied with theirtreatment (270 [97%] of 278 women vs 244 [87%]of 280 women; adjusted percentage difference 9·8,95% CI 5·1–14·5; adjusted odds ratio 2·53, 95% CI 1·83–3·48; p<0·0001) and reported improved quality of life compared with those who were allocated endometrial ablation (180 [69%] of 262 women vs 146 [54%] of 268 women; adjusted percentage difference 13·3, 95% CI 3·8–22·8; adjusted OR 1·87, 95% CI 1·31–2·67; p=0·00058).2Cooper K Breeman S Scott NW et al.Laparoscopic supracervical hysterectomy versus endometrial ablation for women with heavy menstrual bleeding (HEALTH): a parallel-group, open-label, randomised controlled trial.Lancet. 2019; (published online Sept 12.)http://dx.doi.org/10.1016/S0140-6736(19)31790-8Summary Full Text Full Text PDF Scopus (10) Google Scholar There were no differences detected in serious adverse events between the two groups; however, mean operating times (laparoscopic supracervical hysterectomy 114 min [SD 38] vs endometrial ablation 44 min [23]), median time to discharge from operation (laparascopic supracervical hysterectomy 21·5 h [IQR 17·0–26·1] vs endometrial ablation 3·2 h [2·1–5·1]), and median time to return to work (laparascopic supracervical hysterectomy 42 days [37–42] vs endometrial ablation 10 days [7–14]) were longer following laparoscopic supracervical hysterectomy. The real-world implications and worldwide generalisability of this study are where we must now turn our attention. Although this trial specifically examined laparoscopic supracervical hysterectomy, contemporary evidence is lacking with respect to the efficacy and safety of cervix preservation versus removal for heavy menstrual bleeding.4Lethaby A Mukhopadhyay A Naik R Total versus subtotal hysterectomy for benign gynaecological conditions.Cochrane Database Syst Rev. 2012; 4CD004993Crossref PubMed Google Scholar In particular, cervical conservation raises issues of specimen removal, need for cervical screening, and the potential for new or ongoing symptoms secondary to the retained cervical stump. Within a month of recruitment to the HEALTH study, the US Food and Drug Administration issued a safety warning (April 17, 2014) on the use of power morcellation, which was standard in this study, because of a risk of inadvertent spread of undiagnosed malignancy.5US FDALaparoscopic uterine power morcellation in hysterectomy and myomectomy: FDA safety communication.https://www.chartrrg.com/wp-content/uploads/2014/07/FDA-Warning.pdfDate: April 17, 2014Google Scholar This concern is shared by many international committees including the European Society of Gynaecological Oncology, which states that total hysterectomy with en bloc resection is preferred over laparoscopic supracervical hysterectomy.6Halaska MJ Haidopoulos D Guyon F et al.European Society of Gynecological Oncology statement on fibroid and uterine morcellation.Int J Gynecol Cancer. 2017; 27: 189-192Crossref PubMed Scopus (31) Google Scholar Consequently, numbers of laparoscopic supracervical hysterectomies have decreased.7Desai VB Wright JD Lin H et al.Laparoscopic hysterectomy route, resource use, and outcomes: change after power morcellation warning.Obstet Gynecol. 2019; 134: 227-238Crossref PubMed Scopus (11) Google Scholar The long-term potential for reoperation (estimated at up to 20%, secondary to issues related to the cervical stump8van Evert JS Smeenk JM Dijkhuizen FP de Kruif JH Kluivers KB Laparoscopic subtotal hysterectomy versus laparoscopic total hysterectomy: a decade of experience.Gynecol Surg. 2010; 7: 9-12Crossref PubMed Scopus (25) Google Scholar, 9Wallwiener M Taran FA Rothmund R et al.Laparoscopic supracervical hysterectomy (LSH) versus total laparoscopic hysterectomy (TLH): an implementation study in 1952 patients with an analysis of risk factors for conversion to laparotomy and complications, and of procedure-specific re-operations.Arch Gynecol Obstet. 2013; 288: 1329-1339Crossref PubMed Scopus (44) Google Scholar) is not addressed by this study2Cooper K Breeman S Scott NW et al.Laparoscopic supracervical hysterectomy versus endometrial ablation for women with heavy menstrual bleeding (HEALTH): a parallel-group, open-label, randomised controlled trial.Lancet. 2019; (published online Sept 12.)http://dx.doi.org/10.1016/S0140-6736(19)31790-8Summary Full Text Full Text PDF Scopus (10) Google Scholar as longer follow-up of patients would be necessary. Therefore, clinicians might want to await the authors' own ongoing evaluation of total laparoscopic hysterectomy versus laparoscopic supracervical hysterectomy to further determine safety and outcomes of the two approaches.2Cooper K Breeman S Scott NW et al.Laparoscopic supracervical hysterectomy versus endometrial ablation for women with heavy menstrual bleeding (HEALTH): a parallel-group, open-label, randomised controlled trial.Lancet. 2019; (published online Sept 12.)http://dx.doi.org/10.1016/S0140-6736(19)31790-8Summary Full Text Full Text PDF Scopus (10) Google Scholar Although the standard of care provided by the study sites represents real-world experience at the time of study recruitment, we must be cognisant that these standards continue to evolve, thereby shifting the risk-to-benefit ratio for each procedure. Same day discharge is feasible within hours, even after complex total laparoscopic hysterectomy,10Gale J Thompson C Lortie KJ Bougie O Singh SS Early discharge after laparoscopic hysterectomy: a prospective study.J Obstet Gynaecol Can. 2018; 40: 1154-1161Summary Full Text Full Text PDF PubMed Scopus (5) Google Scholar and second-generation ablation can be offered with minimal pain medication in an ambulatory setting (outside the operating room and without general anaesthetic) safely and with even earlier discharge.3NICEHeavy menstrual bleeding: assessment and management.https://www.nice.org.uk/guidance/ng88Date: 2018Google Scholar, 11Reinders I Geomini P Timmermans A de Lange ME Bongers MY Local anaesthesia during endometrial ablation: a systematic review.BJOG. 2017; 124: 190-199Crossref PubMed Scopus (10) Google Scholar, 12Bennett A Lepage C Thavorn K et al.Effectiveness of outpatient versus operating room hysteroscopy for the diagnosis and treatment of uterine conditions: a systematic review and meta-analysis.J Obstet Gynaecol Can. 2019; 41: 930-941Summary Full Text Full Text PDF PubMed Scopus (5) Google Scholar Hospital discharge, hospital stay, and general anaesthetic administration might affect patient decisions and short-term experience. We recognise that a randomised trial is the gold standard of evidence-based practice; however, patients who enrol in such trials eliminate their personal preference in the decision-making process, which is often an important factor in real-world practice. A patient empowered with appropriate counselling and autonomy in the decision-making process is less likely to regret the decision, even if the option selected leads to additional intervention in the future. For example, many of our patients might select endometrial ablation in a setting without a general anaesthetic, minimal recovery, and almost no postoperative pain while acknowledging that there remains a 20% chance of hysterectomy in their future. The completion of a successful multicentre randomised trial of this size in benign surgical gynaecology should be acknowledged. Although heavy menstrual bleeding is common, alternative treatments, particularly surgical treatments, are under-evaluated in randomised trials. Clinicians often reserve surgical management and hysterectomy for patients after they have tried medical therapy. The HEALTH trial highlights that surgical management for heavy menstrual bleeding (both laparoscopic supracervical hysterectomy and endometrial ablation) is safe, effective, and leads to high patient satisfaction.2Cooper K Breeman S Scott NW et al.Laparoscopic supracervical hysterectomy versus endometrial ablation for women with heavy menstrual bleeding (HEALTH): a parallel-group, open-label, randomised controlled trial.Lancet. 2019; (published online Sept 12.)http://dx.doi.org/10.1016/S0140-6736(19)31790-8Summary Full Text Full Text PDF Scopus (10) Google Scholar Although this study alone will not completely change practice because of the complexities mentioned in this Comment, it will offer another set of data to help counsel patients, aiding delivery of evidence-based, patient-centred care for women with heavy menstrual bleeding. OB reports research grants from Allergan and Bayer, and personal fees from Allergan, AbbVie, Bayer, and Hologic, outside the area of work commented on here. SS reports research grants from Allergan, AbbVie, and Bayer, and personal fees from Allergan, AbbVie, Bayer, Hologic, and Cooper Surgical, outside the area of work commented on here. Laparoscopic supracervical hysterectomy versus endometrial ablation for women with heavy menstrual bleeding (HEALTH): a parallel-group, open-label, randomised controlled trialLaparoscopic supracervical hysterectomy is superior to endometrial ablation in terms of clinical effectiveness and has a similar proportion of complications, but takes longer to perform and is associated with a longer recovery. Full-Text PDF Open Access

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