Commissioning Brief - Background Information

Transcription

1 Commissioning Brief - Background Information Laparoscopic hysterectomy This background document provides further information to support applicants for this call. It is intended to summarize what prompted the call and the existing evidence base, including relevant work from the HTA and wider NIHR research portfolio. It was researched and written on the basis of information from a search of relevant sources and databases, and in consultation with a number of experts in the field. Searches and information provided were up to date as of September Patient group This research targets women undergoing a hysterectomy. Information from Hysterectomies are carried out to treat conditions that affect the female reproductive system, including: heavy periods, long-term pelvic pain, fibroids, and cancerous tumours of the female reproductive system. This brief focusses on benign conditions only The type of hysterectomy required depends on how much of the womb (uterus) and surrounding reproductive system needs to be removed. For example: o total hysterectomy the womb and cervix (neck of the womb) are removed; this is the most commonly performed operation o subtotal hysterectomy the main body of the womb is removed, leaving the cervix in place o total hysterectomy with bilateral salpingo-oophorectomy the womb, cervix, fallopian tubes and the ovaries are removed o radical hysterectomy the womb and surrounding tissues are removed, including the fallopian tubes, part of the vagina, ovaries, lymph glands and fatty tissue There are three main surgical techniques used to carry out a hysterectomy: o abdominal hysterectomy where the womb is removed through a cut in the lower abdomen o laparoscopic hysterectomy (keyhole surgery) where the womb is removed through several small cuts in the abdomen o vaginal hysterectomy where the womb is removed through a cut in the top of the vagina (usually reserved for prolapse) Hysterectomy is a common operation. In , there were approximately 32,000 hysterectomies performed in English NHS hospitals ( NICE and other guidance Interventional procedures guidance [IPG239] (2007) Laparoscopic techniques for hysterectomy. This guidance reviewed a number of large case series and non-randomised controlled studies, the largest of which was conducted in the UK between and included over 37,000 patients. The VALUE study asked NHS and private hospitals for data on all women undergoing hysterectomies during a 12 month period in England, Wales and Northern Ireland. Guidance: Current evidence on the safety and efficacy of laparoscopic techniques for hysterectomy (including laparoscopically-assisted vaginal hysterectomy [LAVH], laparoscopic hysterectomy Page 1 of 6

2 [LH], laparoscopic supracervical hysterectomy [LSH] and total laparoscopic hysterectomy [TLH]) appears adequate to support their use, provided that normal arrangements are in place for consent, audit and clinical governance. Clinicians should advise women that there is a higher risk of urinary tract injury and of severe bleeding associated with these procedures, in comparison with open surgery. Advanced laparoscopic skills are required for these procedures, and clinicians should undergo special training and mentorship. The Royal College of Obstetricians and Gynaecologists has developed an Advanced Training Skills Module, 'Benign Gynaecological Surgery: Laparoscopy'. Meanwhile, the American College of Obstetricians and Gynaecologists (June 2017) 1 Committee Opinion No. 701 Choosing the route of hysterectomy for benign disease recommends that vaginal hysterectomy is the approach of choice whenever feasible and that laparoscopic hysterectomy is a preferable alternative to open abdominal hysterectomy for those unsuitable for the vaginal approach. Current practice and proposed intervention Currently in the UK the majority of hysterectomies are performed by open abdominal surgery (53%). Around 22% have laparoscopic surgery 2. Therefore, despite the increasing evidence of its clinical and financial advantages, laparoscopic hysterectomy is not yet routine practice in the UK 3. Some consultants argue that the findings of longer operating time and more urinary tract injuries associated with laparoscopic hysterectomy compared to abdominal surgery reflects the learning curve in the included studies, which were typically published over 10 years ago. The main UK trial included in evidence syntheses was a HTA-funded randomised controlled trial published in 2004 comparing abdominal (AH), vaginal and laparoscopic methods of hysterectomy that enrolled 1380 women the EVALUATE study. In brief, the study found that abdominal laparoscopic hysterectomy was associated with a significantly higher risk of major complications and took longer to perform than open AH. Laparoscopic abdominal hysterectomy was, however, associated with less pain, quicker recovery and better short-term QoL after surgery than AH 4. Consultants in current practice argue that the aforementioned downsides of laparoscopic hysterectomy have now been offset by improvements in training, skills and technology in recent years 3 5 and that additional costs associated with laparoscopic surgery may be offset by reduced length of stay 3 5. On the other hand, some consultants argue that the availability of doctors trained in advanced laparoscopic hysterectomies, as well as theatre staff trained in how to use and maintain the equipment is limited. Because training has a long learning curve, the time taken to complete laparoscopic surgery can take many hours. Given that theatre time is finite and expensive, this limits the affordability of this approach. Furthermore, the current tariff for laparoscopic surgery is lower than that for open abdominal surgery yet the cost of equipment is greater, so affordability is a barrier in many centres 6. Reflecting that the last major trial in the UK comparing laparoscopic with other forms of hysterectomy was conducted over 14 years ago, many clinicians consider the findings to be out of date for a number of reasons: the population has changed considerably over this time (there has been a significant increase in the number of overweight and obese women undergoing hysterectomies since 2004, who may benefit from less invasive surgery), the number of hysterectomies being undertaken has increased and will likely continue to do so, the technology has changed and improved and laparoscopic skills have improved considerably over this time too. A randomised controlled trial evaluating laparoscopic abdominal hysterectomy is therefore proposed. Completed research Evidence Synthesis Page 2 of 6

3 Aarts (2015) Surgical approach to hysterectomy for benign gynaecological disease 7. This Cochrane review searched to August 2014 and included 47 studies with 5,102 women. The evidence for most comparisons was of low or moderate quality. Laparoscopic vs abdominal hysterectomy: 25 RCTs, 2983 women. Return to normal activities was shorter in the LH group (MD days, 95% CI to -11.8; six RCTs, 520 women, low quality evidence), but there were more urinary tract injuries in the LH group (odds ratio (OR) 2.4, 95% CI 1.2 to 4.8, 13 RCTs, 2140 women, low quality evidence). No difference in any other primary outcomes. Laparoscopic vs vaginal hysterectomy 16 RCTs, 1440 women. There was no evidence of a difference between the groups for any primary outcomes. Vaginal versus abdominal hysterectomy 9 RCTs, 762 women. Return to normal activities was shorter in the VH group (mean difference (MD) -9.5 days, 95% confidence interval (CI) to -6.4, three RCTs, 176 women, moderate quality evidence). There was no evidence of a difference between the groups for the other primary outcomes. The review concludes that VH appears to be superior to LH and AH, as it is associated with faster return to normal activities. When technically feasible, VH should be performed in preference to AH because of more rapid recovery and fewer febrile episodes postoperatively. Where VH is not possible, LH has some advantages over AH (including more rapid recovery and fewer febrile episodes and wound or abdominal wall infections), but these are offset by a longer operating time. Primary Research Only one further randomised trial, conducted in India - Nanavati (2016) A Prospective Randomized Comparative Study of Vaginal, Abdominal, and Laparoscopic Hysterectomies 10 - was identified. This small trial randomised 150 women who were suitable for every technique, equally to the three groups. There is a lack of statistical analysis of the results in the publication but broadly it appears that laparoscopic hysterectomy was associated with lower blood loss but longer operating time compared to the other techniques. There is unclear randomisation allocation and no details about when the study was conducted. The study is of very low quality. A number of observational studies have been published in the meantime, but with inconsistent results, and none from the UK were identified: Billfeldt (2018) A Swedish population-based evaluation of benign hysterectomy, comparing minimally invasive and abdominal surgery. This prospective observational study collected data on 13,806 hysterectomy cases from This included abdominal (AH, n=7,485), conventional laparoscopic (LH, n=1,539), vaginal (VH, n=3,767) and robotically assisted (RAH, n=1,015). The study found that the LH group had a longer mean operation time (127 min) vs. AH (97 min). The percentage of hysterectomies with estimated blood loss 500 ml was higher in the AH group (13.4%) compared with LH at 7.6%. Postoperative hospitalization days (AH= 2.5, LH= 1.6), patient-reported time to resuming normal activities of daily living (AH= 7.9, LH= 6.1) and return to work (AH= 35.2, LH= 27) were longer for AH. However, this study found that hospital readmission was higher in the LH group (4.1%) than the AH group (1.9%). In their analysis of patient characteristics, women in the AH group were older and their preoperatively estimated uterus size larger compared with the other groups. Uccella (2017) Laparoscopic Versus Open Hysterectomy for Benign Disease in Uteri Weighing >1 kg: A Retrospective Analysis on 258 Patients 11. In this study, 55 women underwent open surgery and 203 had a laparoscopic procedure at a single sire in Italy. A further 9 patients converted from laparoscopic to open. In brief, laparoscopic took longer than open surgery (120 mins vs 85), but estimated blood loss and length of hospital stay were reduced by a statistically significant margin. Furthermore, the overall rate of complications and incidence of severe complications was significantly lower in the laparoscopic group. The authors do, however, highlight that the level of experience and availability of dedicated centres is important. Lykke (2017) Hysterectomy technique and risk of pelvic organ prolapse repair: a Danish nationwide cohort study 12. This observational study of 178,282 women who underwent hysterectomy between 1977 and 2016 included 134,684 who had an abdominal hysterectomy (including supravaginal and total), Page 3 of 6

4 26,648 who had a vaginal procedure and 12,950 who had laparoscopic hysterectomy (including vaginally assisted). For women that did not have evidence of pelvic organ prolapse at the time of surgery, the cumulative risk of undergoing POP surgery after hysterectomy was similar between the abdominal hysterectomy (27%) group and the laparoscopic group (25%). Lonky (2017) Hysterectomy for benign conditions: Complications relative to surgical approach and other variables that lead to post-operative readmission within 90 days of surgery 13. This retrospective cohort study of 3,106 women in the US found that 109 patients (3.5%) experienced 168 post-operative complications. In summary, patients who underwent total vaginal hysterectomy (odds ratio 2.13, CI ), laparoscopic supracervical hysterectomy (OR 3.11, CI ), and total laparoscopic hysterectomy (odds ratio = 5.60, confidence interval = ) experienced increased occurrence of post-operative complications resulting in readmission. It should be noted that one of the limitations of this study is the relatively low numbers of complications on which these calculations are based. Kayatas (2017) Comparison of libido, Female Sexual Function Index, and Arizona scores in women who underwent laparoscopic or conventional abdominal hysterectomy 14. This observational study among 77 women in a single centre in Turkey saw them assigned to laparoscopic or open abdominal hysterectomy according to the surgeons preference. Female sexual function scores were obtained before and six months after the operation. In summary, the scores were similar both before and after the procedure for both types of hysterectomy. Inal (2017) Comparison of abdominal, vaginal, and laparoscopic hysterectomies in a tertiary care hospital in Turkey 15. This retrospective observational study compared clinical outcomes among a total of 2163 patients who underwent abdominal hysterectomy AH (n = 1226), vaginal hysterectomy VH (n = 426), and laparoscopic hysterectomy LH (n = 511) procedures. In summary, while the groups were similar in regards to BMI, parity, and intra- or postoperative major and minor complications, blood loss was significantly lower in the LH group than in the others (p < 0.001), and hospital duration of stay and analgesic needs were shortest in this group too (p<0.001). However, operation time was significantly shorter in the VH group than in the other two groups (p < 0.001). Research in progress Evidence Synthesis None identified during searches. Primary Research NCT Surgical Success After Laparoscopic vs Abdominal Hysterectomy. A randomised trial. N=100, estimated completion Dec Competed but not yet published. US. SLCTR/2016/020 Cost evaluation, quality of life and pelvic organ function of three approaches to hysterectomy for benign uterine conditions: a multi-centre randomized controlled trial. N=147, estimated completion not stated. Sri Lanka. NIHR research The HTA programme has previously funded a similar trial to that proposed in this brief: HTA project 94/16/03: A randomised trial to assess the effectiveness, costs and cost-effectiveness of laparoscopic, vaginal and abdominal hysterectomy. Published in /hta8260: EVALUATE hysterectomy trial: a multicentre randomised trial comparing abdominal, vaginal and laparoscopic methods of hysterectomy. Conclusions: Abdominal laparoscopic hysterectomy (ALH) is associated with a significantly higher risk of major complications and takes longer to perform than abdominal hysterectomy (AH). ALH is, however, associated with less pain, quicker recovery and better short-term QoL after surgery than AH. The costeffectiveness of ALH is finely balanced and is also influenced by the choice of reusable versus disposable equipment. Individual surgeons must decide between patient-orientated benefits and the risk of severe complications. Vaginal laparoscopic hysterectomy (VLH) was not cost-effective relative to vaginal hysterectomy (VH). Page 4 of 6

5 Other studies relating to either hysterectomy or laparoscopic procedures: NICE TAR 04/44/01: Clinical effectiveness and cost-effectiveness of laparoscopic surgery for colorectal cancer: systematic reviews and economic evaluation. Published NICE TAR 03/31/01: Laparoscopic surgery for inguinal hernia repair: systematic review of effectiveness and economic evaluation. Published HTA (Cochrane) 13/180/14: Robotic Assisted Gynaecological Surgery. Published HTA project 09/14/02: Systematic review and economic modelling of the relative clinical benefit and cost-effectiveness of laparoscopic surgery and robotic surgery for removal of the prostate in men with localised prostate cancer. Published References 1. Committee Opinion No. 701 Summary: Choosing The Route Of Hysterectomy For Benign Disease. Obstetrics and gynecology 2017;129(6): doi: /aog [published Online First: 2017/05/26] 2. Mayor S. Risks from less invasive hysterectomy are quantified in study. BMJ (Clinical research ed) 2016;355:i5775. doi: /bmj.i5775 [published Online First: 2016/10/28] 3. Allam M, Ewies AA. Centres that do not offer TLH as their primary method of hysterectomy should be considered outdated and not Fit for Purpose: FOR: It is a patient's right to be offered laparoscopic surgery as an informed choice. BJOG : an international journal of obstetrics and gynaecology 2016;123(7):1192. doi: / [published Online First: 2016/05/21] 4. Garry R, Fountain J, Brown J, et al. EVALUATE hysterectomy trial: a multicentre randomised trial comparing abdominal, vaginal and laparoscopic methods of hysterectomy. Health technology assessment (Winchester, England) 2004;8(26): [published Online First: 2004/06/25] 5. Bongers M. Advances in laparoscopic surgery have made vaginal hysterectomy in the absence of prolapse obsolete: FOR: The laparoscopic approach is suitable for almost all hysterectomies. BJOG : an international journal of obstetrics and gynaecology 2016;123(4):633. doi: / [published Online First: 2016/02/26] 6. Downey G. Centres that do not offer TLH as their primary method of hysterectomy should be considered outdated and not Fit for Purpose: AGAINST: To allow one their informed choice may mean others have no choice at all. BJOG : an international journal of obstetrics and gynaecology 2016;123(7):1192. doi: / [published Online First: 2016/05/21] 7. Aarts JW, Nieboer TE, Johnson N, et al. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane database of systematic reviews (Online) 2015(8):Cd doi: / CD pub5 [published Online First: 2015/08/13] 8. Magos A. Advances in laparoscopic surgery have made vaginal hysterectomy in the absence of prolapse obsolete: AGAINST: Vaginal hysterectomy remains the optimum route of surgery. BJOG : an international journal of obstetrics and gynaecology 2016;123(4):633. doi: / [published Online First: 2016/02/26] 9. Moen M, Walter A, Harmanli O, et al. Considerations to improve the evidence-based use of vaginal hysterectomy in benign gynecology. Obstetrics and gynecology 2014;124(3): doi: /aog [published Online First: 2014/08/28] 10. Nanavati AM, Gokral SB. A Prospective Randomized Comparative Study of Vaginal, Abdominal, and Laparoscopic Hysterectomies. Journal of obstetrics and gynaecology of India 2016;66(Suppl 1): doi: /s z [published Online First: 2016/09/22] 11. Uccella S, Morosi C, Marconi N, et al. Laparoscopic Versus Open Hysterectomy for Benign Disease in Uteri Weighing >1 kg: A Retrospective Analysis on 258 Patients. Journal of minimally invasive gynecology 2017 doi: /j.jmig [published Online First: 2017/07/18] 12. Lykke R, Lowenstein E, Blaakaer J, et al. Hysterectomy technique and risk of pelvic organ prolapse repair: a Danish nationwide cohort study. Archives of gynecology and obstetrics 2017 doi: /s [published Online First: 2017/07/25] 13. Lonky NM, Mohan Y, Chiu VY, et al. Hysterectomy for benign conditions: Complications relative to surgical approach and other variables that lead to post-operative readmission within 90 days of surgery. Womens Health (Lond) 2017;13(2): doi: / [published Online First: 2017/07/01] 14. Kayatas S, Ozkaya E, Api M, et al. Comparison of libido, Female Sexual Function Index, and Arizona scores in women who underwent laparoscopic or conventional abdominal hysterectomy. Turkish journal of obstetrics and gynecology 2017;14(2): doi: /tjod [published Online First: 2017/09/16] Page 5 of 6

6 15. Inal ZO, Inal HA. Comparison of abdominal, vaginal, and laparoscopic hysterectomies in a tertiary care hospital in Turkey. Irish journal of medical science 2017 doi: /s [published Online First: 2017/07/21] Page 6 of 6