HEALTH: a randomised comparison of laparoscopic supracervical hysterectomy with endometrial ablation for women with heavy menstrual bleeding - medium-term follow-up at a minimum of five years

Research question: What is the medium-term clinical and cost effectiveness (five to eight years) of Laparoscopic supracervical hysterectomy (LASH) versus Endometrial Ablation (EA) for women with heavy menstrual bleeding? What are the rates and types of further treatments, both medical and surgical for both groups of women? Background: Heavy menstrual bleeding (HMB) is a common problem which has a major impact on women's physical, emotional, social and material quality of life. Where initial medical treatment is unsuccessful, NICE recommends surgical options such as endometrial ablation (EA; destruction of the lining of the uterus) or hysterectomy (removal of the uterus). While EA offers a less invasive surgical option, the uterine lining can regrow requiring further treatment. Conventional hysterectomy, although more effective, is invasive and associated with a higher risk of complications. The HEALTH trial compared EA with a less invasive form of hysterectomy (laparoscopic supracervical hysterectomy or LASH), which removes all of the uterus except the cervix. In the short term (15-months post-randomisation), we found LASH to be superior to EA in terms of clinical effectiveness but more expensive due to higher surgical costs and longer hospital stays. However, the higher failure rate associated with EA could result in LASH being more cost-effective in the longer-term. Therefore, further follow-up of the HEALTH participants are required to inform the cost-effectiveness model. Aim: To determine the medium-term clinical (including need for further treatment) and cost effectiveness of Laparoscopic Supracervical Hysterectomy (LASH) versus Endometrial Ablation (EA) for women with heavy menstrual bleeding randomised between May 2014 and March 2017. Methods: Follow-up of the HEALTH participants to a minimum of five years using questionnaires. The co-primary clinical outcomes are participant-reported satisfaction and the Menorrhagia Multi-Attribute Scale (MMAS; condition specific quality of life outcome). Secondary outcomes include generic health related quality of life, need for further treatment and late onset side effects of treatment. Need for further treatment will use a combination of participant reports and routine data. The economic outcome is incremental cost per quality adjusted life years gained. Analysis will be based on the intention-to-treat principle Timeline: Start 1st March 2023. Months 1-6: study initiation, ethics approval, apply for routine data on further treatments; Months 7-12: data collection (participant reported questionnaires and routine data); Months 13-18: data analysis, interpretation of results, report writing and dissemination Impact and dissemination: The results of this extended follow-up study are expected to have a significant impact on clinical and NHS practice by providing robust evidence regarding the medium-term clinical and economic outcomes following LASH or EA. The results of the trial will be disseminated nationally through the British Society for Gynaecological Endoscopy (BSGE), which is responsible for guiding clinical practice, research priorities, governance and training in endoscopic surgery.