Ablation vs Hysterectomy Ablation vs Hysterectomy in Heavy Menstual in Heavy Menstual

BleedingBleedingProfessor Galal Lotfi, MD, MRCOGProfessor Galal Lotfi, MD, MRCOG

BackgroundBackground

a.The Problema.The Problem

• Menorrhagia is an important cause of ill health in women.

• One in 20 women in the UK aged 30-49 consult their General Practitioner (GP) each year with HMB (Vessey 1992).

• It affects about 22% of otherwise healthy premenopausal women aged more than 35 years (Gath 1987).

b.Managementb.Management

• First line is drugs ; in 1993 in the UK, 345,225 women were given 821,700 medical prescriptions.

• This cost 7,176,595UK Pounds to control HMB (EHCB 1995). • Surgical treatment of HMB often follows failed medical therapy and the

definitive treatment is hysterectomy. • Hysterectomy is invariably successful and is one of the few surgical

procedures associated with a 100% primary success rate and high levels of satisfaction.

• 60% of GP referrals for HMB in the UK were treated with hysterectomy within 5 years (Coulter 1991). A cohort study reports that in at least a third of these cases a normal uterus was removed (Clarke 1995).

• Moreover, hysterectomy is a major surgical procedure with significant physical and emotional complications and social and economic costs.

c. Recentlyc. Recently• In the mid 1980s, Endometrial ablation techniques were introduced. The

endometrium has phenomenal powers of regeneration and to suppress menstruation successfully it is essential to remove the full thickness with the superficial myometrium, including the deep basal glands which are believed to be the primary foci for endometrial regrowth. This tissue may be removed under direct hysteroscopic view either by excision with an electrosurgical loop or by ablating the endometrium with some form of thermal energy of sufficient power to produce necrosis the full thickness of the endometrium.

• Endometrial destruction techniques included electrocautery (80%), laser (18%) and radiofrequency (2%) (RCOG 1995).

• The benefits claimed for these less invasive therapies are reduced trauma and post-operative complications, reduced need for a general anaesthetic, direct cost savings due largely to a shift from inpatient to day case treatment and indirect cost savings to society as women return more quickly to their usual activities (Wickham 1991).

Which to choose?Which to choose?

• Do we choose at our own interest.

• Do we choose at our own expertise.

• Do we choose at patient interest

• Do we choose at patient’s request

Objectives Objectives

• The truth is more important than the facts.– Frank Lloyd Wright

?which way to go?which way to go

Test the the hypotheses that endometrial desruction: 1 Are as effective as hysterectomy in the objective and

subjective improvement of the woman's MBL. 2 Are as effective as hysterectomy in the objective and

subjective improvement of the woman's quality of life. 3 Result in a shorter operating time and shorter hospital

stay. 4 Result in return to work sooner than those undergoing a

hysterectomy. 5 Result in fewer adverse events than those undergoing

hysterectomy. 6 ls a cost effective alternative to hysterectomy.

Types of studies reviewedTypes of studies reviewed

• All randomised controlled comparisons of removal and ablation of the endometrium (by resection, rollerball, laser or other) versus hysterectomy (any type) for the reduction of HMB.

• Exclusion criteria: – Postmenopausal bleeding ( >1 year from the last

period) .– Irregular menses and intermenstrual bleeding .– Pathological causes of HMB (e.g. uterine cancer) – Iatrogenic causes of HMB (e.g. intrauterine coil

devices) .

Outcome measures to compareOutcome measures to compare

a.MBLa.MBL

• Objective assessment of improvement in MBL.

• Subjective assessment of improvement in MBL.

b.Quality of lifeb.Quality of life

c.Length of hospital stay c.Length of hospital stay

d.Time to return to workd.Time to return to work

e. Duration of surgerye. Duration of surgery

f.Rate of satisfactionf.Rate of satisfaction

• - within 1 year after surgery

• - at 2 years

• - at 3 years

• - at 4 years

e.Adverse events: e.Adverse events:

• Frequency of specific adverse events both before and after discharge from hospital

• Resource use/cost • Requirement for further surgery for menstrual

symptoms – - during 1st year after surgery – - after 2 years of follow up – - after 3 years of follow up – - after 4 years of follow up

• Mortality

Surgical techniques usedSurgical techniques used

• Endom Ablation techniques included combined ablation (diathermy loop and rollerball used together), resection (diathermy loop used alone), rollerball (rollerball diathermy used alone), laser ablation (laser energy used), radiofrequency ablation (radiothermal energy used) and the newer techniques of cryoablation (freezing used), thermal balloon ablation (heated balloon used) and photodynamic therapy.

• Hysterectomy can be performed via the abdomen, vagina or with the assistance of the laparoscope.. Subgroup analysis was not performed according to the type of hysterectomy since data were not available in separate form for two trials.

Studies reviewedStudies reviewed

• Five RCT comparing ablation of the endometrium with hysterectomy by any route for HMB were identified. Two of these trials had multiple publications each based on the same study population but assessing different outcomes, different follow up times and a cost-utility analysis of previously published data (Dwyer 1993, Pinion 1994).

• Trials comparing different types of endometrial destruction were not considered in this review.

Results: HMBResults: HMB

• There was a significant advantage in favour of hysterectomy in the improvement of HMB. Menstrual bleeding no longer occurred after hysterectomy.

• After endom ablation, at one year follow up, MBL was not reduced from pre-surgical levels in a proportion (13%) (OR=0.12, 95% CI 0.06-0.25).

• After longer follow up, the differences in improvement in MBL between the 2 surgical groups appeared to narrow, possibly as a result of re-treatment in the endometrial ablation group or women reaching the menopause.

Results: SatisfactionResults: Satisfaction

• Satisfaction (very or moderately satisfied) rates were significantly higher among those who had a hysterectomy both at one and two years after surgery when compared to satisfaction rates among those who had endometrial destruction.

• There were no significant differences between post-treatment satisfaction rates in groups at longer (3 and 4 years) follow up in two separate studies.

Results: Quality of lifeResults: Quality of life

• Quality of life was measured by a variety of scales included for example, the Golombok Rust Inventory of Marital State, Euroqol Scale, Sabbatsberg Sexual Rating Scale, the Hospital Anxiety and Depression Scale (HAD) and the Short Form 36 Questionnaire (SF-36). There were no differences between the two groups in their adjustment measured by the psychosocial adjustment to illness scale (Alexander 1996 (Pinion 1994)). Women having a hysterectomy reported significantly higher scores on the social functioning, pain and general health perception domains.

• A greater proportion of those who had a hysterectomy reported an improvement in their general health one year after surgery when compared to those who had endometrial destruction. At 4 years, this difference between groups had narrowed and was just outside the 0.05 level of significance.

Results: Surgery durat…..Results: Surgery durat…..

• The outcomes, duration of surgery and hospital stay and time to return to work were all significantly shorter with endometrial destruction when compared with hysterectomy.

• Duration of surgery was reduced by a mean of 23 minutes,

• Hospital stay was reduced by a mean of 5 days,• Time to return to work reduced by a mean of 4

1/2 weeks.

Results: ComplicationsResults: Complications

• Most short term complications were more frequent after hysterectomy when compared to endometrial ablation.

• Women having a hysterectomy had a greater risk of – sepsis, – blood transfusion, – urinary retention, – anaemia, – pyrexia, – vault and wound haematoma and – cautery of hypergranulation before their hospital discharge.

• Those having endometrial ablation were more likely to have fluid overload when compared to those who had a hysterectomy.

• There were no differences between groups for – haemorrhage, – perforation, – gastrointestinal obstruction and – laparotomy as causes of post-operative complications,

• However at least half of these short term results were based on only one study (Gannon 1991).

Results: Repeat surgeryResults: Repeat surgery

• Risk of repeat surgery for failure of the initial surgical treatment was significantly more likely at all follow up periods, within the first year and at 2, 3 and 4 years after the initial surgical procedure for endometrial destruction when compared with hysterectomy .

• In one study, by 4 years, 38% of women who had endometrial destruction had required repeat surgery for menstrual problems compared to 1% of those who had a hysterectomy in an intention to treat analysis (2 of 105 patients randomised to hysterectomy had endometrial ablation).

Results: CostResults: Cost

• All three trials evaluating costs reported that endometrial resection cost the health service less than hysterectomy.

• This difference remained over a prolonged follow up time but the cost gap narrowed primarily because of the re-treatment rate for women having an endometrial resection.

• By 4 years, ablation techniques cost between 5% and 11% less than a hysterectomy in one study evaluating long follow up (Aberdeen 1999 (Pinion 1994)).

• One trial (Cameron 1996 (Pinion 1994)) measured costs to the women. At one year of follow-up, total personal costs, in terms of travel, loss of pay and child care, were higher for women having a hysterectomy than for women having endometrial ablation. However, women having a hysterectomy estimated a significantly greater saving in cost of sanitary protection than those having endometrial ablation did (saving of UK pounds 85.10 per year versus UK pounds 58.30 per year).

ConclusionConclusion

1. Patient satisfaction, favour hyst1. Patient satisfaction, favour hyst

• Hysterectomy was completely successful in treating HMB and had very high levels ( >95%) of participant satisfaction up to 3 years after surgery.

• Ablation were also highly successful in reducing menstrual blood loss in most participants but a proportion (varying from 3 to 13%) had no improvement.

• At 2 year follow up, women having a hysterectomy were significantly more satisfied compared with women having hysteroscopic ablation.

• At 1 year follow up, women experienced significantly greater reduction in MBL compared with women having hysteroscopic ablation.

• These differences were no longer apparent at longer periods of follow up, possibly due to reduced numbers and re-treatment in the endometrial ablation group.

2. Quality of life, favour Hyst2. Quality of life, favour Hyst

• Those who had a hysterectomy perceived a greater benefit in their general health compared to those who had hysteroscopy both 1 and 2 years after surgery and an improvement in social functioning and perceived pain at 2 years.

• All other aspects of quality of life did not differ between groups.

• This review has demonstrated considerable short term benefits of endometrial destruction techniques when compared with hysterectomy.

3. Surgery, favour ablation3. Surgery, favour ablation

• Duration of surgery (difference of 23 minutes),

• hospital stay (difference of 5 days) and

• time to return to work (difference of 4.5 weeks) were significantly shorter for those who had endometrial destruction.

4. Post op complications4. Post op complications• Women having a hysterectomy experienced more post-operative

complications than women having endometrial destruction did. • Although endometrial destruction is very effective for most women and

high rates of satisfaction, an increasing proportion of these women require repeat surgery, either repeat endometrial ablation or hysterectomy.

• In one study, at a minimum of 4 years of follow up (Aberdeen 1999 from Pinion 1994 study), 38% of those who had endometrial ablation received further surgical treatment of some kind compared to 1% of those who had a hysterectomy, although 76% of the total group of endometrial ablation patients still avoided a hysterectomy.

• A recent UK audit of the commonly used techniques found that ablation by laser and rollerball were significantly safer than endometrial resection but all techniques had a low complication rate of 4.4% (Overton 1997). For four of the five included studies, transcervical endometrial resection (TCRE) was used to ablate the endometrium; the fifth study required a 1:1 ratio of TCRE and laser ablation but there was insufficient statistical power to compare the two techniques. Thus, for the purposes of this review, all techniques used to destroy the endometrium were combined.

5. Cost, favour?5. Cost, favour?• Evaluation of comparative costs between the two surgical procedures is affected by

the increasing re-treatment rate. Initially, costs are much lower for endometrial ablation but the difference narrows over time because of the cost of re-treatment.

• In one study with a minimum of 4 years follow up, endometrial ablation was reported to be only 5 to 11% less costly than the cost of hysterectomy compared to 24% and 29% less costly at one and two years of follow up.

• One study concluded that abdominal hysterectomy is likely to be more cost effective than endometrial resection if health care purchasers were willing to pay an additional cost of at least UK pounds 6,500 per extra quality-adjusted life-year generated by hysterectomy although there is an area of uncertainty attached to this conclusion by variations in the parameters used in the analysis.

• Another study found that a preference based treatment allocation was more cost-effective than reliance on a single intervention for all women requiring surgery for HMB. Evaluation of comparative cost effectiveness of endometrial destruction techniques and hysterectomy is complex and the simple conclusion that endometrial destruction is cheaper than hysterectomy, with the difference narrowing over time, may not be an adequate economic assessment.

EpilogEpilog

1. Implications for practice1. Implications for practice

• Endometrial destruction is an alternative to hysterectomy that should be offered to women with HMB.

• There are high satisfaction rates, shorter operation time and hospital stay, earlier recovery and reduced post-operative complications.

• There should, however, be a preoperative discussion of the possibility of further surgery being necessary for those women who choose endometrial ablation for the relief of their HMB.

2. Implications for research2. Implications for research

There is a need for additional trials in the following areas:

• 1. Comparison of the more other types of hysterectomy (vaginal and laparoscopically assisted vaginal) with endometrial ablation. There is good evidence that vaginal hysterectomy is associated with shorter recovery time and fewer complications than hysterectomy by the abdominal route (Langebrekke 1996).

• 2. Trials with longer follow up to adequately assess the cost differential between the two types of surgery and requirement for further surgical treatment in women randomised to endometrial destruction techniques.