Hysterectomy or Endometrial AbLaTion for Heavy menstrual bleeding
Research type
Research Study
Full title
A multicentre randomised controlled trial comparing laparoscopic supra-cervical hysterectomy with second generation endometrial ablation for the treatment of heavy menstrual bleeding (HEALTH)
IRAS ID
139913
Contact name
Siladitya Bhattacharya
Contact email
Sponsor organisation
University of Aberdeen & NHS Grampian
Research summary
Heavy menstrual bleeding (HMB) was a common problem affecting approximately 1.5 million women in England and Wales with a major impact on their physical, emotional, social and material quality of life. It was the fourth most common reason why women attended gynaecology outpatients clinics and accounted for 20% of all gynaecology outpatient referrals.
In women with HMB resistant to medical treatment, NICE recommended endometrial ablation (EA) ie destruction of the lining of the womb or hysterectomy ie removal of the womb. A systematic review had shown that hysterectomy resulted in higher satisfaction rates and revealed that a quarter of all women who underwent EA would require subsequent gynaecological surgery, with just under a fifth requiring hysterectomy for persistent symptoms. These findings suggested that the most effective surgical treatment for HMB not responsive to medical treatment might well be hysterectomy, but this needed to be balanced against its invasiveness and short and long-term complications associated with it.
Unlike conventional hysterectomy, laparoscopic supra-cervical hysterectomy (LASH) aimed to use keyhole techniques via the abdominal route to remove the body of the uterus which was responsible for menstrual bleeding. The cervix, removal of which added to the complications associated with the procedure was left behind and women needed to continue to have cervical smears. It was minimally invasive, quick, relatively easy to learn and associated with low morbidity, short hospital stay (under 24 hours) and rapid recovery. It could thus potentially offer women and surgeons the benefit of a total hysterectomy with the minimal invasiveness of endometrial ablation. The HEALTH study would undertake a robust evaluation of the comparative effectiveness of the LASH surgical option and would provide high quality evidence to determine whether or not it should be adopted widely in the NHS.
REC name
North of Scotland Research Ethics Committee 2
REC reference
13/NS/0155
Date of REC Opinion
6 Jan 2014
REC opinion
Further Information Favourable Opinion