Which Hysterectomy for Heavy Menstrual Bleeding? Ray Garry

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1 Which Hysterectomy for Heavy Menstrual Bleeding? Ray Garry

3 I do not believe it! Victor Meldrew

4 Insert Interim heading Clinical depending Commissioning Insert Insert heading depending on line on Policy: line length; length; Hysterectomy please please delete delete for on on line line length; please delete delete other Menorrhagia other cover cover options once once other cover options once you have chosen one. 20pt you you have have chosen one. one. 20pt 20pt Agreed: November 2013 Ref: N-SC/020 Hysterectomy Low Priority Procedure not usually funded.

5 Hysterectomy, endometrial ablation and Mirena for heavy menstrual bleeding: a systematic review of clinical effectiveness HTA Bhattacharya S et al HTA 2011 April 15:iii-xvi Roberts TE: Hysterectomy more clinically effective Hysterectomy more cost effective

Management of Heavy Menstruation Jones and Watson Edinburgh 1839-40 There is nothing, however, so effectual in

6 Management of Heavy Menstruation Jones and Watson Edinburgh There is nothing, however, so effectual in checking menorrhagia as general blood letting and it is sometimes requisite to carry it to a considerable extent

7 Influences

8 Results

9 How to Choose? Cochrane believed that the ultimate duty of doctors was to make decisions between alternative therapies based on cost/benefit comparisons. He believed these can really only be obtained by adequate RCTs

12 The Laparotomy Syndrome

13 Laparotomy Syndrome Wound Pain Exposure and Handling of Bowel Local Ileus further pain Peritoneal Trauma Respiratory Dysfunction and hypoxia Need for Strong Opiates Resulting in Nausea, Vomiting with prolonged IV Extended Convalescence. Impaired Abdominal Wall Function

14 Avoiding Laparotomy Syndrome

15 How to do Hysterectomy? : LH v AH Less operative pain Shorter Hospital Stay Quicker Recovery Earlier return of sexual activity Better short term QALYs

16 Costs of approach WHAT IS COST- EFFECTIVENESS? Benefits of approach Less More More Dominated Usual Less Occasional Dominate

17 LH V AH COST-EFFECTIVENESS Cost Lap-assisted 1687 Abdominal 1496 Difference in cost* 95% confidence interval 191 (- 41, 366) QALYs over one year Difference in QALYs* 95% confidence interval (-0.011, 0.031) Laparoscopic costs 17,363 per additional QALY (191/0.011)

18 VH v LH Natural Orifice Transaluminal Surgery 16 trials of 1440 women No benefits in favour of LH VH quicker VH cheaper VH higher QALY VH less complications

19 LH v VH COST-EFFECTIVENESS Cost Lap-assiste 1641 Vaginal 1246 Difference in cost* 95% confidence interval 396 ( 265, 547) QALYs over one year Difference in QALYs* 95% confidence interval (-0.019, 0.020) LH cost 267,333 per additional QALY Vaginal dominates laparoscopic-assisted

20 Cochrane Review 2015: Vaginal hysterectomy should be performed whenever possible. When not possible, both laparoscopic and abdominal hysterectomy have their pros and cons

21 ACOG: Choosing the Route of Hysterectomy for benign disease Number 701 June 2017 The vaginal approach is preferred Laparoscopic hysterectomy is often an acceptable alternative Open abdominal hysterectomy remains an important surgical option for some patients

22 Changes in Hysterectomy Rates for yr olds in Australia De Cure N et al MIS 2018;ID per 10000/year 2015 per 10000/year AH (-53%) VH (-53%) LH (+153%)

23 FINHYST: Brummer et al Hum Reprod 2011;26: 1741 Benign hysterectomies in Finland ; AH=abdominal hysterectomy, VH=vaginal hysterectomy, 6645 LH=laparoscopic hysterectomy, ALL=all benign hysterectomies AH VH LH ALL

24 Daily Mail 12 th June 2010 A robot did my hysterectomy: How a smart machine has perfected the operation

25 The Role of Robotic Hysterectomy in Benign Disease Noam Smorgick Int J Women s Health No clinically meaningful differences in outcomes between robotic and laparoscopic hysterectomy. Number of robotic hysterectomies in the US was 263,000 cases in 2015.

26 A systematic review and meta-analysis of Robotic v LH Roh HF PLOS doi.org/10.137/journal pone RH does not result in better treatment outcomes, except for less blood loss Operative time and total complication rates better with LH than RH

27 Estimate of Cost Effectiveness of RH v VH 3,641,000 per QALY

28 Subtotal v Total hysterectomy Lethaby A Cochrane Review April 2012 Subtotal does not improve sexual, urinary or bowel function Continued risks of ungoing cyclical bleeding Cervical cancer risk persists and smears still required Progesterone required in any HRT

29 New Developments in Robotics and Single-Site Gynecologic Surgery C Matthews Clin Obstet Gynecol 2017;60:296 Single-port hysterectomy has not improved postoperative pain or subjective cosmetic results.

31 Robotic Vaginal Hysterectomy Baekelandt J: J Gynec Surg 2016;32:270 Da Vinci side docked between legs: hysterectomy completed with Robot: then colpotomy repaired with classical techniques RVANH is technically possible Further Technical developments required to avoid arm collisions

www.endoscopyforum.com Video/photo s 2015-17.

32 Video/photo s Drag down Second Endoscopy Forum Kate O Hanlon: Extolling the Virtues of the Unspeakable in Gynecology

33 Purposeful Prevention of Future Problems Hysterectomy + BSO allows HRT with estrogen alone Prevents uterine, cervical, tubal and ovarian cancers Treats menopausal symptoms without harm Improves sexual and bladder function Reduces risk of breast cancer by 50% and MI by 20%

34 Why doesn t evidence influence practice? Evidence Statutory and Medical Bodies What Actually Happens Resources and Traditions Patient and Marketing

35 A Self-Evident Truth? The uterus is secured and removed according to identical principles whatever the mode of access The only variables affecting clinical outcomes are those related to differences in the methods of access and are generic to that method Any method of avoiding the laparotomy syndrome will produce virtually identical long term results

36 Conclusion: Which Hysterectomy VH is the procedure of choice when technically possible LH is a useful alternative especially when associated with deep pelvic, side wall or adnexal disease AH still has indications particularly for large masses Some benefits associated with additional BSO. No current evidence of patient related benefits from Robotic Assisted, subtotal or single site procedures.

37 THANK YOU

40 Conclusion 1 (When Hysterectomy?) Women should be offered all therapeutic options with full explanation of pros and cons of each and be able to choose Hysterectomy is almost 100% effective and may be of high value to some women with heavy menstrual bleeding In some circumstances hysterectomy should be offered as first therapeutic option

41 Patient satisfaction with Hysterectomy Kjerulff KH et al Am J Obstet Gynecol 2000;183: Prospective study of 1299 women 24 months after hysterectomy: 96% symptoms completely or mostly resolved 94% results better or as expected 93% reported being totally recovered

42 Breast Cancer Risks Soni et al Obstet Gynecol 2014;124:292 Soini et al Acta Oncol :188 Morch LS et al. NEJM 2017;377:2228 Sieglmaann-Danieli Breast can Res treat 2018;167: %-20% SIR increased risk of breast cancer in women taking LNG-IUS over the age of 40 years.

43 Insert Interim heading Clinical depending Commissioning Insert Insert heading depending on line on Policy: line length; length; Hysterectomy please please delete delete for on on line line length; please delete delete other Menorrhagia other cover cover options once once other cover options once you have chosen one. 20pt you you have have chosen one. one. 20pt 20pt Agreed: November 2013 Ref: N-SC/020

45 RCT s: VH v LH Trial Year Number Country Result Summitt RL US VH = LH Richardson UK VH > LH Ottosen C Sweden VH > LH Darai E France VH = LH Hwang JL Taiwan VH = LH Riberio SC Brazil VH > LH Garry R UK VH > LH Agostini A France VH > LH Morelli M Italy LH > VH Drahonovsky J Czech Rebulic VH > LH Roy KK India VH > LH 11 RCT s 1581 cases 10 countries 7/3/1

46 Proportion (%) of different types of benign hysterectomies AH=abdominal, VH=vaginal, LH=laparoscopic hysterectomy AH VH LH

47 Heavy Menstrual Bleeding: NICE guidelines (NG88) March 2018 Consider LNG-IUS as first line treatment. If declined consider non-hormonal or hormonal medications It unsuccessful offer EA Only then offer hysterectomy

48 VH similar surgical and Vaginal v Robotic hysterectomy for endometrial oncological cancer Nitschmann CC et al Gynecol Oncol 2017;145: outcomes to RH RH took 1.3 hours longer RH 30 day cost $3150 more

49 Nice Recommendations Explain to women who are offered an LNG-IUS:* about anticipated changes in bleeding pattern, particularly in the first few cycles and maybe lasting longer than 6 months that it is advisable to wait for at least 6 cycles to see the benefits of the treatment Endometrial ablation Advise women to avoid subsequent pregnancy and use effective contraception, if needed, after endometrial ablation Hysterectomy Have a full discussion with all women who are considering hysterectomy about the implications of surgery before a decision is made. The discussion should include: sexual feelings impact on fertility bladder function need for further treatment treatment complications her expectations alternative surgery psychological impact Inform women about the increased risk of serious complications (such as intraoperative haemorrhage or damage to other abdominal organs) associated with hysterectomy when uterine fibroids are present Inform women about the risk of possible loss of ovarian function and its consequences, even if their ovaries are retained during hysterectomy

50 Side Effects of LNG-IUS (Manufacturers Information Sheet) Very Common (more than 1-10): Uterine bleeding disorders and breast tenderness Common (between1 in ): Depressive moods, headaches Decreased libido, acne Abdominal pain and nausea Occasional: Pregnancy and Ectopic

51 Current Costs of Da Vinci Robot Capital Cost: $1.7 million per robot, Annual Maintenance: $125,000 Disposals $2,000 per surgery

52 Intuitive Accounts (2017) Market value $35 Billion Revenue $3.1 billion (16%)

53 Perplexed What happened to putting patient at the centre of the decision making? What happened to basing recommendations on good quality evidence?

54 Hysterectomy Rates by Route of Surgery (Wright et al JAMA 2013;309: ) 264,758 patients in US from

55 Mean (SD) SF-12 scores (abdominal trial). Baseline (n=668) Six weeks (n=449) Four months (n=438) One year (n=478) Physical component summary* Abdominal hysterectomy (11.5) n= (9.7) n= (8.6) n= (9.3) n=148 Laparoscopic hysterectomy (11.7) n= (10.1) n= (8.6) n= (8.4) n=330 Difference (95% Cl) 0.6 ( 1.2 to 2.5) 5.1 ( 7.1 to ( 2.8 to 0.7) 0.9( 2.5 to 0.8) P value Mental component summary Abdominal hysterectomy 45.3 (11.3) n= (10.8) n= (9.5) n= (10.2) n=148 Laparoscopic hysterectomy 45.8 (11.7) n= (11.4) n= (10.5) n= (10.7) n=33 Difference (95% Cl) 0.5 ( 2.4 to 1.4) 1.8 ( 0.4 to 4.0) 0.8( 1.3 to 2.9) 1.1 ( 0.9 to 3.2) P value *A high score represents a better quality of life.

56 Body image scale results (abdominal trial): mean (SD) and difference at each time point Baseline (n=813) 6 weeks (n=529) 4 months (n=505) 1 year n=555) Abdominal hysterectomy 9.0(7.9)(n=270) 5.2(5.9)(n=172) 4.4(6.3) n= (5.7)(n=168 Laparoscopic hysterectomy 8.8(8.1)(n= (4.9)(n=357) 3.3(4.9)(n= (5.2)(n=387 Difference (95% Cl) 0.2 ( 0.9 to ((0.5 to 2.4) 1.1 (0.06 to ( 0.2 to 1.7) P value A low score represents a better body image.

57 Commissioners Response to NICE Guidelines Hysterectomy Low Priority Procedure not usually funded. Funded only after unsuccessful trial of LNG-IUS AND after two medical treatments have failed AND after failed EA

58 National Institute for Health and Care Excellence NICE ia an executive body of the DHS that publishes guidelines: Including guidelines on appropriate treatments and care of people with specific diseases and conditions The appraisals are based primarily on evaluations of efficacy and cost effectiveness

59 30 June 2018 Efficiencies in Patient care NHS England has today set out plans to curb ineffective or risky medical treatments given to hundreds of thousands of patients each year.

60 What is Health Technology Assessment Programme? HTA is largest NIHR programmes that funds independent research about effectiveness, costs and impacts of treatments for those who plan, provide or receive care in the NHS

61 Advice for Heavy Menstrual Bleeding (HMB) Services and Commissioners RCOG November 2014 For patients with severe symptoms and a poor quality of life, surgical treatment could be considered earlier in the decision making process for treatment as it produced the greatest improvement in this group of women.

62 Evaluate Study Mean SF12 Physical Component Scores Baseline 6 weeks 4 months 1 year AH LH Difference Significance P>0.001 p= 0.2 P=0.32

63 Annual, laparoscopic, and open total abdominal hysterectomy procedures performed in England ( )(HES) Year Total Laparos Open

64 Hysterectomy, endometrial ablation and Mirena for heavy menstrual bleeding: a systematic review of clinical effectiveness HTA Bhattacharya S et al HTA 2011 April 15:iii-xvi Despite longer hospital stay and time to resume activities more women are satisfied after hysterectomy than after EA Limited evidence but that which is available suggests hysterectomy also preferred to Mirena

65 Hysterectomy, endometrial ablation, and levonorgestrel releasing intrauterine system for treatment of heavy menstrual bleeding: cost effectiveness analysis Roberts TE: Although more expensive, Hysterectomy produces more QALYs and is more cost effective than Mirena and EA.

66 Hysterectomy, endometrial ablation, and levonorgestrel releasing intrauterine system for treatment of heavy menstrual bleeding: cost effectiveness analysis Roberts TE: bmj.com/content/342/bmj.d2202 In light of the acceptable thresholds used by N.I.C.E., hysterectomy would be considered the preferred first intervention strategy for the treatment of heavy menstrual bleeding.

Hysterectomy Fact versus fiction. Richard Dover Specialist Gynaecologist

Hysterectomy Fact versus fiction Richard Dover Specialist Gynaecologist Disclaimer Disclaimer Hysterectomy An update? Myths busted? HYSTERECTOMY Retro-chic! HMB Important cause of morbidity Affects