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NIHR Signal Keyhole hysterectomy is effective for women with heavy menstrual bleeding

Published on 12 November 2019

doi: 10.3310/signal-000837

When surgical treatment was needed, almost all women with heavy menstrual bleeding were satisfied and had a good quality of life following keyhole surgery to remove the uterus. Slightly fewer achieve this with ablation to remove the uterine lining.

In a UK randomised trial, women given one or other treatment in NHS hospitals reported good benefits after both interventions, which also had similar, low rates of adverse effects. In total, 97% were satisfied with the effects a year after laparoscopic supracervical hysterectomy (which retains the cervix). However, 87% were also satisfied after endometrial (uterine lining) ablation, which was quicker to perform and had a faster recovery.

The study suggests that both options have advantages and could be appropriate choices for women, based on their personal preferences. While more women were satisfied with the results of their hysterectomy a year after surgery, some women may prefer to try a less invasive treatment with a quicker recovery time first.

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Why was this study needed?

Surgical options for women with heavy menstrual bleeding are normally only offered after insertion of a progesterone releasing coil or other medical treatment. However, many women find that surgery is necessary.

Choices for surgery include different types of endometrial ablation, aimed at destroying the uterine lining that causes heavy menstrual bleeding, removal of fibroids if present, and hysterectomy.

Techniques available for ablation and hysterectomy have advanced in recent years. While open hysterectomy is still widely used, laparoscopic supracervical hysterectomy (which removes only the body of the uterus, leaving the cervix in place) is an option that is becoming easier to perform, avoids some of the risks to the bladder and offers quicker post-op recovery. The technology for ablation has also become simpler to use.

There have been few large-scale studies comparing newer therapies. This study was intended to compare laparoscopic supracervical hysterectomy with second-generation endometrial ablation.

What did this study do?

Researchers recruited 660 women in 31 UK hospitals into a randomised controlled trial (the HEALTH trial). Women were aged less than 50 years and had been referred for surgical treatment of heavy menstrual bleeding. All were eligible for endometrial ablation.

After randomisation, women were added to the local waiting lists for their allocated procedure. They were assessed 15 months after randomisation for satisfaction with treatment and with a condition-specific quality of life measure.

The researchers reported treatment-associated adverse events, length of procedure, time to discharge from hospital and to return to everyday activities.

Because of the nature of the treatments, the surgeons and the participants were aware of their treatment allocation. The trial was carefully conducted and biases minimised, making the results reliable. The treatments and settings were not adapted for this trial, so the results should be applicable in normal NHS practice.

What did it find?

  • About 12 months after the procedure, 97% of women allocated to hysterectomy and 87% of women allocated to ablation were satisfied with their treatment (adjusted difference 9.8%, 95% confidence interval 5.1 to 14.5).
  • The maximum score possible on the menorrhagia quality of life scale used (MMAS) is 100, and this was achieved in 69% of women allocated to hysterectomy and 54% of women allocated to ablation 12 months after the procedure.
  • An adverse event such as infection, pain or catheterisation for longer than 72 hours affected 5% of women allocated to hysterectomy and 4% of women allocated to ablation. A further operation was necessary for 6% of women who had ablation by 15 months post-randomisation, and this was mostly hysterectomy. There was no evidence of bladder damage or complications for women having a hysterectomy.
  • Women in the ablation group returned to paid work after a median of 10 days, compared with 42 days for women in the hysterectomy group.
  • Women in the ablation group were discharged after an average of 3.2 hours, compared with 21.5 hours for women in the hysterectomy group.

What does current guidance say on this issue?

In a 2019 guideline, NICE says that women with heavy menstrual bleeding should first be offered a progesterone-releasing intrauterine system or other medical therapy.

Surgical options to consider if required include second-generation endometrial ablation or hysterectomy. The guideline says: “When discussing the route of hysterectomy (laparoscopy, laparotomy or vaginal) with the woman, carry out an individual assessment and take her preferences into account”.

The guidance continues: “Discuss the options of total hysterectomy (removal of the uterus and the cervix) and subtotal hysterectomy (removal of the uterus and retention of the cervix) with the woman”.

What are the implications?

The study suggests that either supracervical laparoscopic hysterectomy or endometrial ablation could be appropriate for women with heavy menstrual bleeding who require surgical intervention.

While hysterectomy provided the greatest satisfaction and a lower rate of reoperation within 12 months, it may not be the preferred first choice of all women because of the longer recovery time and duration of hospital stay.

The comparable and low rate of complications suggests a similar level of risk for the two procedures, in contrast to previous studies which found more complications after hysterectomy.

Citation and Funding

Cooper K, Breeman S, Scott NW et al. Laparoscopic supracervical hysterectomy versus endometrial ablation for women with heavy menstrual bleeding (HEALTH): a parallel-group, open-label, randomised controlled trial. Lancet. 2019;394:1425-36.

The study was funded by the NIHR Health Technology Assessment Programme (project number 12/35/23).

Bibliography

NICE. Heavy menstrual bleeding: assessment and management. NG88. London: National Institute for Health and Care Excellence; updated November 2018.

Singh S and Bougie O. HEALTH for heavy menstrual bleeding: real-world implications. Lancet. 2019;394:1390-92.

Why was this study needed?

Surgical options for women with heavy menstrual bleeding are normally only offered after insertion of a progesterone releasing coil or other medical treatment. However, many women find that surgery is necessary.

Choices for surgery include different types of endometrial ablation, aimed at destroying the uterine lining that causes heavy menstrual bleeding, removal of fibroids if present, and hysterectomy.

Techniques available for ablation and hysterectomy have advanced in recent years. While open hysterectomy is still widely used, laparoscopic supracervical hysterectomy (which removes only the body of the uterus, leaving the cervix in place) is an option that is becoming easier to perform, avoids some of the risks to the bladder and offers quicker post-op recovery. The technology for ablation has also become simpler to use.

There have been few large-scale studies comparing newer therapies. This study was intended to compare laparoscopic supracervical hysterectomy with second-generation endometrial ablation.

What did this study do?

Researchers recruited 660 women in 31 UK hospitals into a randomised controlled trial (the HEALTH trial). Women were aged less than 50 years and had been referred for surgical treatment of heavy menstrual bleeding. All were eligible for endometrial ablation.

After randomisation, women were added to the local waiting lists for their allocated procedure. They were assessed 15 months after randomisation for satisfaction with treatment and with a condition-specific quality of life measure.

The researchers reported treatment-associated adverse events, length of procedure, time to discharge from hospital and to return to everyday activities.

Because of the nature of the treatments, the surgeons and the participants were aware of their treatment allocation. The trial was carefully conducted and biases minimised, making the results reliable. The treatments and settings were not adapted for this trial, so the results should be applicable in normal NHS practice.

What did it find?

  • About 12 months after the procedure, 97% of women allocated to hysterectomy and 87% of women allocated to ablation were satisfied with their treatment (adjusted difference 9.8%, 95% confidence interval 5.1 to 14.5).
  • The maximum score possible on the menorrhagia quality of life scale used (MMAS) is 100, and this was achieved in 69% of women allocated to hysterectomy and 54% of women allocated to ablation 12 months after the procedure.
  • An adverse event such as infection, pain or catheterisation for longer than 72 hours affected 5% of women allocated to hysterectomy and 4% of women allocated to ablation. A further operation was necessary for 6% of women who had ablation by 15 months post-randomisation, and this was mostly hysterectomy. There was no evidence of bladder damage or complications for women having a hysterectomy.
  • Women in the ablation group returned to paid work after a median of 10 days, compared with 42 days for women in the hysterectomy group.
  • Women in the ablation group were discharged after an average of 3.2 hours, compared with 21.5 hours for women in the hysterectomy group.

What does current guidance say on this issue?

In a 2019 guideline, NICE says that women with heavy menstrual bleeding should first be offered a progesterone-releasing intrauterine system or other medical therapy.

Surgical options to consider if required include second-generation endometrial ablation or hysterectomy. The guideline says: “When discussing the route of hysterectomy (laparoscopy, laparotomy or vaginal) with the woman, carry out an individual assessment and take her preferences into account”.

The guidance continues: “Discuss the options of total hysterectomy (removal of the uterus and the cervix) and subtotal hysterectomy (removal of the uterus and retention of the cervix) with the woman”.

What are the implications?

The study suggests that either supracervical laparoscopic hysterectomy or endometrial ablation could be appropriate for women with heavy menstrual bleeding who require surgical intervention.

While hysterectomy provided the greatest satisfaction and a lower rate of reoperation within 12 months, it may not be the preferred first choice of all women because of the longer recovery time and duration of hospital stay.

The comparable and low rate of complications suggests a similar level of risk for the two procedures, in contrast to previous studies which found more complications after hysterectomy.

Citation and Funding

Cooper K, Breeman S, Scott NW et al. Laparoscopic supracervical hysterectomy versus endometrial ablation for women with heavy menstrual bleeding (HEALTH): a parallel-group, open-label, randomised controlled trial. Lancet. 2019;394:1425-36.

The study was funded by the NIHR Health Technology Assessment Programme (project number 12/35/23).

Bibliography

NICE. Heavy menstrual bleeding: assessment and management. NG88. London: National Institute for Health and Care Excellence; updated November 2018.

Singh S and Bougie O. HEALTH for heavy menstrual bleeding: real-world implications. Lancet. 2019;394:1390-92.

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

Published on 2 October 2019

Cooper K, Breeman S, Scott N W, Scotland G, Hernández R, Clark T J, Hawe J, Hawthorn R, Phillips K, Wileman S, McCormack K, Norrie J & Bhattacharya S.

Health Technology Assessment Volume 23 Issue 53 , 2019

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.

Expert commentary

According to the HEALTH trial, for women with heavy periods who have had failed medical treatment with a levonorgestrel intrauterine system, laparoscopic supracervical hysterectomy is better than endometrial ablation.

The trial was well conducted. Although the registry classed it as “retrospectively registered”, with three primary outcomes changing to two co-primaries in the final report, registration was actually prospective, the outcome changes were well documented and justified in the analysis plan, and the results were highly statistically significant. Losses to follow-up were higher than expected, but we can be confident there was no data dredging. Operative complication rates were very low in both groups.

For women who can find a surgeon with equally low complication rates, supracervical hysterectomy is a good option.

Jim Thornton, Professor of Obstetrics and Gynaecology, Faculty of Medicine and Health Sciences, University of Nottingham

The commentator declares no conflicting interests

Expert commentary

Heavy menstrual bleeding affects a significant number of women, and this study shows that if surgery is required then laparoscopic supracervical hysterectomy results in better satisfaction compared to endometrial ablation. However, more advanced training, skills and equipment, such as morcellators, are required for laparoscopic surgery.

Conversely, endometrial ablation is possible to be done under local anaesthesia, which has a faster training curve with quicker recovery times. There are also potential unknown effects regarding the long term follow up from retaining the cervical stump. More research will be required to address such concerns.

Janesh Gupta, Professor of Obstetrics and Gynaecology, Centre for Women’s and Newborn Health; Birmingham Women’s and Children’s NHS Foundation Trust; Editor-in-Chief of EJOG

The commentator declares no conflicting interests

Expert commentary

HEALTH is one of the largest studies completed for surgical treatments for heavy menstrual bleeding (HMB). This study provides the woman and her surgeon with clear information about expectations following keyhole removal of the womb (hysterectomy) or destruction of the womb lining (ablation).

The primary outcomes measured reflect the practical and pragmatic current definition for HMB as a symptom impairing quality of life. This information will enhance and refine decision-making in clinical practice. Performing ablation treatment without a general anaesthetic may be an even more attractive option for women who favour this treatment and value a quicker recovery. 

Mayank Madhra, Consultant Gynaecologist, Royal Infirmary of Edinburgh

The commentator declares no conflicting interests

Expert commentary

This pragmatic RCT demonstrates that LASH (Laparoscopic Assisted Supracervical Hysterectomy) achieves equivalent satisfaction rates to total hysterectomy (TH) but importantly with the low and equivalent complication rates to those seen with endometrial ablation (EA) surgeries.

The study was well designed, adequately powered and achieved good follow up rates. The results are highly generalisable, being relevant to everyday clinical practice. This paper will enhance decision making for clinicians and patients for a common clinical condition.

What this trial clearly shows is that when taking women to theatre for surgery for HMB then they will do significantly better with a LASH.

Stuart A Jack, Surgical Lead of EXPPECT Endometriosis, Consultant Gynaecologist, NHS Lothian