HEALTH LTFU
Research type
Research Study
Full title
Hysterectomy or Endometrial AbLation Trial for Heavy menstrual bleeding: 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 - A Longer-Term Follow-Up (LTFU) of the HEALTH trial.
IRAS ID
334039
Contact name
Kevin Cooper
Contact email
Sponsor organisation
University of Aberdeen
Duration of Study in the UK
0 years, 5 months, 31 days
Research summary
Heavy menstrual bleeding (HMB) affects 1 in 4 British women. Many will require surgical treatment in the form of endometrial ablation (destruction of the lining of the uterus) or hysterectomy (removal of the uterus). Endometrial ablation (EA) offers a less invasive surgical option; however, many women will need repeat EA and a proportion will ultimately need hysterectomy for recurrence of symptoms.
In the NIHR HTA funded HEALTH trial (HTA project 12/35/23; IRAS 139913) we compared a less invasive form of hysterectomy (laparoscopic supracervical hysterectomy or LASH) which removes all of the uterus except the cervix, with EA in 660 women seeking surgical treatment for HMB. Findings indicated that women undergoing LASH had greater satisfaction at 15 months post-randomisation but had longer hospital stay and return to normal activities. Economic evaluation indicated an additional immediate cost of £1,604 per woman compared to EA producing 0.004 additional QALYs. Longer term follow up is required to establish whether the cost-effectiveness ratio may improve over time, as suggested by modelling incorporating external data. It is essential that the longer-term clinical and economic outcomes of LASH and EA, including further treatment rates, are compared through follow-up of the HEALTH trial.
During the consent process the HEALTH participants agreed, or not, to be contacted about medium-term follow-up. The target population for the HEALTH LTFU study will therefore include the 648 women who consented to being contacted about medium-term follow-up and who did not withdraw from receiving further study questionnaires or die during the initial 15-month post-randomisation period.
We will collect participant-reported outcomes using a single participant questionnaire. The need for further surgery will use a combination of participant-reported accounts and routine data sources.
REC name
London - Chelsea Research Ethics Committee
REC reference
24/PR/0170
Date of REC Opinion
14 Mar 2024
REC opinion
Further Information Favourable Opinion