Lothian NHS Board Waverley Gate 2-4 Waterloo Place Edinburgh EH1 3EG Telephone 0131 536 9000 Fax 0131 536 9088 www.nhslothian.scot.nhs.uk Date: 06/06/2014 Our ref: 4496 Enquiries to: Bryony Pillath Extension: 35676 Direct Line: 0131 465 5676 bryony.pillath@nhslothian.scot.nhs.uk Dear FREEDOM OF INFORMATION ENDOMETRIAL CANCER I write in response to your request for information in relation to treatment for endometrial cancer in NHS Lothian. 1. How many cases of endometrial cancer were diagnosed in NHS Lothian is the latest three years for which figures are available? I am advised that endometrial cancer incidence data is available from the Cancer Registry Data published on the National Services Scotland Information Services Division s website, which goes back to 1988. The page can be accessed here: http://www.isdscotland.org/health-topics/cancer/cancer-statistics/female-genital-organ/ The table below shows the incidence rate for the last three available years, taken from the Information Services Division website. Cancers of the Corpus Uterus in NHS Lothian Year Number diagnosed 2010 117 2011 95 2012 94 2. When was this new procedure [total laparoscopic hysterectomy] introduced into the Royal Infirmary of Edinburgh? We have been conducting total laparoscopic hysterectomy (TLH) in Edinburgh since 2009. Total laparoscopic hysterectomy is accepted practice in the treatment of endometrial cancer; I have enclosed the guidance from NICE (National Institute for Health and Clinical Headquarters Waverley Gate, 2-4 Waterloo Place, Edinburgh EH1 3EG Chair Brian Houston Chief Executive Tim Davison Lothian NHS Board is the common name of Lothian Health Board
4496 Endometrial Cancer June 2014 Excellence) with this response. Total laparoscopic hysterectomy for type 2 or high grade disease is currently undertaken by one of three sub-speciality accredited Gynaecology Oncologists. In selected cases where there is grade 1 disease, there are a number of gynaecologists with the necessary surgical skills to undertake surgery. 3. Please supply a copy of the patient pathway used by multi-disciplinary healthcare professionals to move the patient through the tests and treatment to be provided by this new procedure [total laparoscopic hysterectomy]. The pathway for referral of patients with suspected endometrial cancer currently under review by the South East of Scotland Cancer Network (SCAN) and expected to be published in September 2014. An outline of the current patient pathway is as follows: Patients with proven endometrial cancer will be seen by either the gynaecology team at hospitals in Lothian in cases of low grade tumours, or at one of the three rapid access clinics at the Royal Infirmary of Edinburgh or the Western General Hospital in cases where there is high grade disease. A clinical assessment will establish whether the patient is a suitable candidate for total laparoscopic hysterectomy. Patients with high grade or type 2 tumour histology will have full CT (computerised tomography scan staging assessments and there will be discussion by at the multi-disciplinary team meeting held every Thursday. Some reasons why a patient may not be suitable for a total laparoscopic hysterectomy include a significantly enlarged uterus, proven evidence of metastatic spread of disease, or significant anaesthetic risk factors (affecting a small number of patients). The guarantee date for surgery is 31 days from the date of decision to operate, and 62 days from initial urgent referral. This guarantee has been in place from January 2012 and was audited by the National Services Scotland Information Services Division in 2012. 4. Please supply a copy of any documentation which the patient may expect to receive to support them through this new procedure [total laparoscopic hysterectomy]. This should include the template of the patient specific treatment plan given to each service user. Consent for surgery would be obtained from the patient after discussion about surgical risk and complications. Patients may be referred to a clinical nurse specialist or to the South East of Scotland Cancer Network (SCAN) website for further information. The web address for the SCAN website is: http://www.scan.scot.nhs.uk/pages/default.aspx.
4496 Endometrial Cancer June 2014 Once total laparoscopic hysterectomy has been decided on, all patients will be seen at a pre-clerking visit to discuss further details of hospital admission, time in hospital, and ward policy. Patients will generally be admitted on the day of surgery and spend one to two days as an inpatient. Arrangements will be made to discuss whether any further treatment is required. I hope the information provided helps with your request. If you are unhappy with our response to your request, you do have the right to request us to review it. Your request should be made within 40 working days of receipt of this letter, and we will reply within 20 working days of receipt. If our decision is unchanged following a review and you remain dissatisfied with this, you then have the right to make a formal complaint to the Scottish Information Commissioner. If you require a review of our decision to be carried out, please write to the FOI Reviewer at the address at the head of this letter. The review will be undertaken by a Reviewer who was not involved in the original decision-making process. FOI responses (subject to redaction of personal information) may appear on NHS Lothian s Freedom of Information website at: http://www.nhslothian.scot.nhs.uk/yourrights/foi/pages/default.aspx Yours sincerely ALAN BOYTER Director of Human Resources and Organisational Development Cc: Chief Executive Enc.
Issue date: September 2010 NHS National Institute for Health and Clinical Excellence Laparoscopic hysterectomy (including laparoscopic total hysterectomy and laparoscopically assisted vaginal hysterectomy) for endometrial cancer 1 Guidance 1.1 Current evidence on the safety and efficacy of laparoscopic hysterectomy (including laparoscopic total hysterectomy and laparoscopically assisted vaginal hysterectomy) for endometrial cancer is adequate to support the use of this procedure provided that normal arrangements are in place for clinical governance, consent and audit. 1.2 Patient selection for laparoscopic hysterectomy for endometrial cancer should be carried out by a multidisciplinary gynaecological oncology team. 1.3 Advanced laparoscopic skills are required for this procedure and clinicians should undergo special training and mentorship. The Royal College of Obstetricians and Gynaecologists has developed an Advanced Training Skills Module, which is available from www.rcog.org.uk/curriculummodule/advanced-laparoscopic-surgeryexcision-benign-disease. This needs to be supplemented by further training to achieve the skills required for laparoscopic hysterectomy for endometrial cancer. 1.4 Long-term follow-up data on recurrence and survival following laparoscopic hysterectomy for endometrial cancer would assist any future review of the procedure by NICE. 2 The procedure 2.1 Indications and current treatments 2.1.1 The uterus is the fourth most common site of malignancy among women in the UK, and endometrial cancer is the most common type of uterine cancer. The predominant symptom of endometrial cancer is abnormal vaginal bleeding, especially in postmenopausal women. 2.1.2 The International Federation of Gynecology and Obstetrics (FIGO) system is used to stage endometrial cancer from stage I(cancer confined to the uterus) to stage IV (cancer that has spread to another body organ). 2.1.3 Endometrial cancer is usually treated by total hysterectomy with bilateral salpingooophorectomy. Radiotherapy, hormone therapy and chemotherapy may also be used. 2.2 Outline of the procedure 2.2.1 The aim of a laparoscopic approach to hysterectomy is to provide a treatment option with smaller incisions and scars, shorter hospital stay and shorter recovery period than for open surgery. 2.2.2 Laparoscopic hysterectomy is usually carried out with the patient under general anaesthesia. Several small incisions provide access for the laparoscope and surgical instruments. The abdomen is insufflated with carbon dioxide. The uterus, supporting ligaments and the upper vagina are removed. Sometimes, the pelvic and para-aortic lymph nodes are also removed. The uterus is removed vaginally. The other tissues can be removed vaginally or through the abdominal incisions. Sections 2.3 and 2.4 describe efficacy and safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview, available at www.nice.org.uk/ip811overview Interventional procedure guidance 356 This guidance makes recommendations on the safety and efficacy of the procedure. It does not cover whether or not the NHS should fund a procedure. Funding decisions are taken by local NHS bodies after considering the clinical effectiveness of the procedure and whether it represents value for money for the NHS. This guidance is for healthcare professionals and people using the NHS in England, Wales, Scotland and Northern Ireland, and is endorsed by NHS QIS for implementation by NHSScotland. NHS Evidence accredited provider NHS Evidence -provided by NICE www.evidence.nhs.uk
2.3 Efficacy 2.3.1 In a meta-analysis, 3 randomised-controlled trials (RCTs) including a total of 359 patients treated by laparoscopic hysterectomy or by abdominal hysterectomy reported overall survival rates of 92% (169/184) and 88% (154/175) respectively (p = 0.976) and disease-free survival rates of 88% (161/184) and 88% (154/175) respectively (p =0.986) at follow-up of amaximum of 36 months. 2.3.2 Anon-randomised comparative study of 309 patients reported 5-year overall survival rates of 98% both for patients treated by laparoscopic (n = 165) and abdominal (n = 144) hysterectomy. The 5-year progression-free survival rate was 96% for patients after laparoscopic hysterectomy and 97% for patients after abdominal hysterectomy (p = 0.74). 2.3.3 Hospital stay after laparoscopic hysterectomy was significantly shorter than after abdominal hysterectomy in the RCTs of 159 and 122 patients (2 days vs 5days, p<0.01; 8days vs 11 days, p = 0.001 respectively). The proportion of patients staying in hospital for more than 2 days was significantly higher after abdominal hysterectomy compared with laparoscopic hysterectomy (94% vs 52%, p<0.0001) in the RCT of 2616 patients. 2.3.4 The Specialist Advisers listed key efficacy outcomes as overall survival, recurrence rate, quality of life, operative time and length of hospital stay. 2.4 Safety 2.4.1 Rates of conversion to laparotomy were reported as 26% (434/1682), 0% (0/81), 8% (5/63), 5% (10/188), 5% (11/226) and 5% (4/73) among patients treated by laparoscopic hysterectomy in RCTs of 2616,159 and 122 patients, and non-randomised comparative studies of 309, 510 and 169 patients respectively. 2.4.2 The RCT of 2616 patients treated by laparoscopic or abdominal hysterectomy reported no significant difference in the rate of intraoperative complications (10% [160/1682] vs 8% [69/909], p = 0.106) but significantly fewer postoperative complications after laparoscopic compared with abdominal hysterectomy (14% [240/1682] vs 21% [191/909], p<0.001). 2.4.3 The meta-analysis including a total of 498 patients reported no significant difference in the rate of intraoperative complications for patients treated by laparoscopic compared with abdominal hysterectomy (8% [14/169] vs 12% [19/162], p = 0.39). Significantly fewer postoperative complications were reported associated with laparoscopic compared with abdominal hysterectomy in the same study (17% [27/158] vs 32% [50/155], p=0.007). 2.4.4 The RCT of 2616 patients and the non-randomised comparative study of 309 patients reported intraoperative complications of bowel injury (2% [37/1682] and less than 1% [1/165]), vascular injury (4% [75/1682] and 1% [2/165]), bladder injury (1% [21/1682 and 2/165]) and ureter injury (less than 1% [14/1682 and 1/165]) among patients treated by laparoscopic hysterectomy. 2.4.5 In the non-randomised comparative study of 309 patients treated by laparoscopic or abdominal hysterectomy, intra-abdominal abscess was reported in 2% (4/165) and 6% (8/144) of patients respectively. 2.4.6 The RCT of 84 patients reported port-site recurrence in 1 of 40 patients treated by laparoscopic hysterectomy after a median 79-month follow-up. 2.4.7 The non-randomised comparative study of 309 patients treated by laparoscopic or abdominal hysterectomy reported bladder dysfunction in 1 patient in each group (1/165 and 1/144 respectively). 2.4.8 The Specialist Advisers listed adverse events reported in the literature as conversion to open surgery, damage to abdominal or pelvic structures, respiratory difficulties, port-site herniation and port-site metastasis. They reported dehiscence of the vaginal vault after laparoscopic suturing as an anecdotal adverse event. 3 Further information 3.1 For related NICE guidance see www.nice.org.uk Information for patients NICE has produced information on this procedure for patients and carers ( Understanding NICE guidance ). It explains the nature of the procedure and the guidance issued by NICE, and has been written with patient consent in mind. See www.nice.org.uk/guidance/ipg356/publicinfo Ordering printed copies Contact NICE publications (phone 0845 003 7783 or email publications@nice.org.uk) and quote reference number N2295 for this guidance or N2296 for the Understanding NICE guidance. Thisguidance representsthe viewofnice, which was arrivedatafter carefulconsiderationofthe available evidence.healthcare professionals areexpected to take it fullyinto account whenexercisingtheir clinical judgement. This guidance doesnot, however, override the individual responsibility of healthcareprofessionalstomake appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer. Implementation of this guidance is the responsibilityoflocal commissioners and/orproviders. Commissioners and providers are reminded that it is theirresponsibility to implement the guidance, in theirlocalcontext, in light of theirdutiestoavoidunlawful discrimination andtohave regard to promoting equality of opportunity.nothinginthis guidance should be interpretedinaway whichwouldbeinconsistent with compliancewith thoseduties. National Institute for Health and ClinicalExcellence, 2010. All rights reserved.this material may be freely reproduced for educationaland not-for-profit purposes. No reproductionbyorfor commercialorganisations, or for commercial purposes,isallowed without the express writtenpermissionofnice. National Institute for Health and Clinical Excellence ISBN 978-1-84936-349-5 MidCity Place, 71 High Holborn, London WC1V 6NA; www.nice.org.uk N2295 1P 3.7k Sep 10