Woman Man
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Extract
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 [email protected]
Inclusion criteria
- Heavy menstrual bleeding