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Cover of Laparoscopic supracervical hysterectomy compared with second-generation endometrial ablation for heavy menstrual bleeding: the HEALTH RCT

Laparoscopic supracervical hysterectomy compared with second-generation endometrial ablation for heavy menstrual bleeding: the HEALTH RCT

Health Technology Assessment, No. 23.53

, , , , , , , , , , , , and ; on behalf of the HEALTH Study Group.

Author Information
Southampton (UK): NIHR Journals Library; .

Headline

Hysterectomy was associated with higher patient satisfaction and better quality of life at 15 months than endometrial ablation but it was more costly in the short term

Abstract

Background:

Heavy menstrual bleeding (HMB) is a common problem that affects many British women. When initial medical treatment is unsuccessful, the National Institute for Health and Care Excellence recommends surgical options such as endometrial ablation (EA) or hysterectomy. Although clinically and economically more effective than EA, total hysterectomy necessitates a longer hospital stay and is associated with slower recovery and a higher risk of complications. Improvements in endoscopic equipment and training have made laparoscopic supracervical hysterectomy (LASH) accessible to most gynaecologists. This operation could preserve the advantages of total hysterectomy and reduce the risk of complications.

Objectives:

To compare the clinical effectiveness and cost-effectiveness of LASH with second-generation EA in women with HMB.

Design:

A parallel-group, multicentre, randomised controlled trial. Allocation was by remote web-based randomisation (1 : 1 ratio). Surgeons and participants were not blinded to the allocated procedure.

Setting:

Thirty-one UK secondary and tertiary hospitals.

Participants:

Women aged < 50 years with HMB. Exclusion criteria included plans to conceive; endometrial atypia; abnormal cytology; uterine cavity size > 11 cm; any fibroids > 3 cm; contraindications to laparoscopic surgery; previous EA; and inability to give informed consent or complete trial paperwork.

Interventions:

LASH compared with second-generation EA.

Main outcome measures:

Co-primary clinical outcome measures were (1) patient satisfaction and (2) Menorrhagia Multi-Attribute Quality-of-Life Scale (MMAS) score at 15 months post randomisation. The primary economic outcome was incremental cost (NHS perspective) per quality-adjusted life-year (QALY) gained.

Results:

A total of 330 participants were randomised to each group (total n = 660). Women randomised to LASH were more likely to be satisfied with their treatment than those randomised to EA (97.1% vs. 87.1%) [adjusted difference in proportions 0.10, 95% confidence interval (CI) 0.05 to 0.15; adjusted odds ratio (OR) from ordinal logistic regression (OLR) 2.53, 95% CI 1.83 to 3.48; p < 0.001]. Women randomised to LASH were also more likely to have the best possible MMAS score of 100 (68.7% vs. 54.5%) (adjusted difference in proportions 0.13, 95% CI 0.04 to 0.23; adjusted OR from OLR 1.87, 95% CI 1.31 to 2.67; p = 0.001). Serious adverse event rates were low and similar in both groups (4.5% vs. 3.6%). There was a significant difference in adjusted mean costs between LASH (£2886) and EA (£1282) at 15 months, but no significant difference in QALYs. Based on an extrapolation of expected differences in cost and QALYs out to 10 years, LASH cost an additional £1362 for an average QALY gain of 0.11, equating to an incremental cost-effectiveness ratio of £12,314 per QALY. Probabilities of cost-effectiveness were 53%, 71% and 80% at cost-effectiveness thresholds of £13,000, £20,000 and £30,000 per QALY gained, respectively.

Limitations:

Follow-up data beyond 15 months post randomisation are not available to inform cost-effectiveness.

Conclusion:

LASH is superior to EA in terms of clinical effectiveness. EA is less costly in the short term, but expected higher retreatment rates mean that LASH could be considered cost-effective by 10 years post procedure.

Future work:

Retreatment rates, satisfaction and quality-of-life scores at 10-year follow-up will help to inform long-term cost-effectiveness.

TriaI registration:

Current Controlled Trials ISRCTN49013893.

Funding:

This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 53. See the NIHR Journals Library website for further project information.

Contents

About the Series

Health Technology Assessment
ISSN (Print): 1366-5278
ISSN (Electronic): 2046-4924

Article history

The research reported in this issue of the journal was funded by the HTA programme as project number 12/35/23. The contractual start date was in January 2014. The draft report began editorial review in October 2018 and was accepted for publication in February 2019. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report.

Declared competing interests of authors

T Justin Clark reports grants and personal fees from Hologic Inc. (Santa Clara, CA, USA), outside the submitted work, and membership of the Health Technology Assessment (HTA) Prioritisation Committee. John Norrie declares grants from the University of Aberdeen and the University of Edinburgh during the conduct of the study, and membership of the following National Institute for Health Research (NIHR) boards: HTA Commissioning Board (2010–16); NIHR HTA and Efficacy and Mechanism Evaluation Editorial Board (2014–19); HTA Commissioning Sub-board (Expression of Interest) (2016–present); HTA Funding Boards Policy Group (2016–present); HTA General Board (2016–present); HTA Post-board Funding Teleconference (2016–present); the Pre-exposure Prophylaxis Impact Review Panel (2018); and the NIHR Clinical Trials Unit Standing Advisory Committee (2018–present). Siladitya Bhattacharya is the Editor-in-Chief of HROpen and an Editor for Cochrane Gynaecology and Fertility.

Last reviewed: October 2018; Accepted: February 2019.

Copyright © Queen’s Printer and Controller of HMSO 2019. This work was produced by Cooper et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.
Bookshelf ID: NBK547194DOI: 10.3310/hta23530

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