Plain English Summary
Background and study aims
Heavy menstrual bleeding (HMB) is a very common and distressing condition which affects over 1.5 million women in the UK. It is responsible for one in 20 women consulting their general practitioner (GP) and accounts for 20% of hospital referrals in gynaecology. Initial treatment usually involves the use of drugs, including the combined oral contraceptive pill, as well as a hormone-impregnated intrauterine contraceptive device. However, these may be unsuitable or unsuccessful in some women, who will need surgical treatment. The main aim of this study is to compare the clinical and cost effectiveness of two different surgical treatments: laparoscopic supra-cervical hysterectomy (LASH) and endometrial ablation (EA) for the treatment of HMB.
Who can participate?
Women less than 50 years of age with heavy menstrual bleeding (HMB) eligible for surgical treatment can take part.
What does the study involve?
Eligible women will be randomly allocated to undergo either LASH or EA. All participants will be asked to complete assessment questionnaires at certain time points - before surgery and again at 6 weeks, 6 and 12 months after surgery. Women will also complete a 14-day diary immediately after their operation and a simple questionnaire at 4 weeks after surgery.
What are the possible benefits and risks of participating?
Participants may not benefit personally from taking part in the study but will be directly helping us to generate information which could help plan more effective treatment for women with heavy periods. We do not think that there are any additional risks or disadvantages to participating in this study. Whichever group participants are allocated to, their care will be overseen by an experienced consultant gynaecologist. Steps are always taken to make sure that any possible risks are minimised. As part of routine care, participants will be well informed of potential risks.
Where is the study run from?
Patients will be recruited from approximately 26 NHS hospitals in the UK:
Aberdeen Royal Infirmary, Aberdeen; Forth Valley Royal Hospital, Larbert; Countess of Chester Hospital NHS Foundation Trust, Chester; Castle Hill Hospital, Cottingham; Queen Elizabeth Hospital, Edgbaston, Birmingham; Gartnavel Royal Hospital, Glasgow; Sunderland Royal Hospital, Sunderland; The Royal Victoria Infirmary, Newcastle Upon Tyne; Harrogate District Hospital, Harrogate; Northern General Hospital, Sheffield; Worcester Royal Hospital, Worcester; Arrowe Park Hospital, Upton, Wirral; Stepping Hill Hospital, Stockport; Singleton Hospital, Swansea; Royal Cornwall Hospital, Cornwall; Queen Alexandra Hospital, Portsmouth; The Royal Hampshire County Hospital, Winchester; Whipps Cross Hospital, London; Princess Royal University Hospital, Farnborough Common, Kent; Derriford Hospital, Plymouth; The Great Western Hospital, Swindon; St Peter's Hospital, Chertsey, Surrey; Princess Anne Hospital, Southampton; Royal Sussex County Hospital, Brighton; Poole Hospital NHS Foundation Trust; Poole; Worthing Hospital, Worthing.
When is the study starting and how long is it expected to run for?
Recruitment will start in the early summer of 2014 and the study will end in late 2017.
Who is funding the study?
National Institute for Health Research (NIHR), UK.
Who is the main contact?
Centre for Healthcare Randomised Trials
Prof Siladitya Bhattacharya
School of Medicine and Dentistry
University of Aberdeen
Aberdeen Maternity Hospital
Hysterectomy or Endometrial AbLation Trial for Heavy menstrual bleeding. A multicentre randomised controlled trial comparing laparoscopic supra-cervical hysterectomy with second generation endometrial ablation for the treatment of heavy menstrual bleeding
The hypothesis being tested is that laparoscopic supra-cervical hysterectomy is superior to second generation endometrial ablation for the treatment of heavy menstrual bleeding (HMB) in terms of patient satisfaction, quality of life (QoL) and costs.
North of Scotland Research Ethics Service Committee 2, 06/01/2014, ref. 13/NS/0155
Multicentre randomised controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Heavy menstrual bleeding
The patients are randomised to two groups.
The interventions being compared are:
1. Laparoscopic supra-cervical hysterectomy (LASH):
The LASH procedure involves removing the part of your womb that causes menstrual bleeding. This is done by keyhole surgery. Three small cuts on the stomach wall are made. The procedure is done under a general anaesthetic and patients are usually home within 24 hours of the operation. As the cervix is not removed, women still need to have cervical smears in the future.
2. Endometrial ablation (EA): The EA procedure involves placing a thin device in the womb by passing it first through the vagina and then through the cervix. The lining of the womb is destroyed and the device is then removed. EA is done as a day case procedure in hospital. It is usually done under a general anaesthetic but can be under local anaesthetic if preferred. As the uterus is not removed women still need cervical smears in the future.
Primary outcome measures
1. Menorrhagia multi-attribute scale (MMAS), a condition-specific Quality of Life outcome
2. Patient satisfaction, measured on a six point scale (from totally satisfied to totally dissatisfied) measured at 12 months post surgery
3. Incremental cost (to the health service) per quality-adjusted life year (QALY) gained (LASH versus EA)
Secondary outcome measures
1. MMAS at 6 months
2. Patient reported satisfaction at 6 months
3. Acceptability of procedure measured at 6 weeks
4. Severity of post operative pain using a pain Numerical Rating Scale (NRS) measured at 1-14 days and at 6 weeks, symptom diary days 1 to 14 (including analgesic use)
5. Generic health related quality of life (SF-12, EQ-5D 3-L) measured at baseline, 6 and 12 months
6. Sexual Activity Questionnaire (SAQ) at baseline, 6 and 12 months
1. Duration of operation
2. Peri-operative complications and recovery details including analgesia requirements
3. Time to discharge
4. Further gynaecological surgery by 12 months
Wider societal costs associated with changes in productivity based on information on the time taken to return to normal activities (following intervention) combined with questions on work productivity delivered during the follow-up period. Further, a simple Markov model, based on within trial data supplemented by available published data on the requirement for further gynaecological surgery over time (following the alternative procedures) will be developed and used to extrapolate cost-effectiveness beyond 12 months.
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Women less than 50 years of age with heavy menstrual bleeding eligible for endometrial ablation
2. Women who are willing to be randomised between laparoscopic supra-cervical hysterectomy and endometrial ablation
Target number of participants
Participant exclusion criteria
1. Women with plans to conceive, endometrial atypia, uterine cavity size greater than 11 cm, submucosal fibroids distorting the uterine cavity, contradictions for laparoscopic surgery (e.g. midline lower abdominal incision or known intrabdominal / pelvic adhesions) and previous endometrial ablation (EA)
2. Women who are unable to give informed consent or complete trial documentation
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
School of Medicine and Dentistry
National Institute for Health Research (NIHR) (UK) - NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC) - NIHR Health Technology Assessment Programme (HTA), ref: 12/35/23
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting