Interventional procedure consultation document

Laparoscopic hysterectomy (including laparoscopic total hysterectomy and laparoscopically assisted vaginal hysterectomy) for endometrial cancer

Endometrial cancer is cancer of the lining of the womb (uterus), known as the endometrium. The most common symptom is abnormal bleeding from the vagina. Surgery for endometrial cancer usually involves the removal of the uterus (hysterectomy). A laparoscopic hysterectomy is carried out through several small incisions in the abdomen (‘keyhole’ surgery), with the aid of an internal telescope and camera system (laparoscope). 

The National Institute for Health and Clinical Excellence (NICE) is examining laparoscopic hysterectomy (including laparoscopic total hysterectomy and laparoscopically assisted vaginal hysterectomy) for endometrial cancer and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. NICE’s Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about laparoscopic hysterectomy (including laparoscopic total hysterectomy and laparoscopically assisted vaginal hysterectomy) for endometrial cancer.

This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

• comments on the provisional recommendations
• the identification of factual inaccuracies
• additional relevant evidence, with bibliographic references where possible.

Note that this document is not NICE’s formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that NICE will follow after the consultation period ends is as follows.

• The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
• The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.

For further details, see the Interventional Procedures Programme manual, which is available from the NICE website (www.nice.org.uk/ipprogrammemanual).

NICE is committed to promoting through its guidance race and disability equality and equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our guidance on interventional procedures. In particular, we aim to encourage people and organisations from groups in the population who might not normally comment on our guidance to do so. We also ask consultees to highlight any ways in which draft guidance fails to promote equality or tackle discrimination and give suggestions for how it might be improved. NICE reserves the right to summarise and edit comments received during consultations, or not to publish them at all, where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate.

Closing date for comments: 16th June 2010

Target date for publication of guidance: September 2010

1  Provisional recommendations

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/curriculum-module/advanced-laparoscopic-surgery-excision-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  Endometrial cancer is the most common type of uterine cancer, which is the fourth most common cancer in women in the UK. 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 abdominal hysterectomy with bilateral salpingo-oophorectomy. 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 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 along with pelvic lymph nodes and sometimes the para-aortic lymph nodes. These tissues are removed either through one of the abdominal incisions (laparoscopic total hysterectomy) or through the vagina (laparoscopically assisted vaginal hysterectomy).

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

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 with a maximum of 36 months.

2.3.2  A non-randomised comparative study of 309 patients reported similar 5-year overall survival rates of 98% for patients treated by either laparoscopic (n = 165) or 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  In 3 RCTs of 159, 122 and 84 patients treated by laparoscopic or abdominal hysterectomy, rates of recurrence after laparoscopic hysterectomy were 9% (7/81), 13% (8/63) and 20% (8/40) respectively compared with 12% (9/78), 8% (5/59) and 18% (7/38) after abdominal hysterectomy.

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), 5% (10/188), 5% (11/226), 5% (4/73) and 8% (5/63) among patients treated by laparoscopic hysterectomy in an RCT of 2616 and non-randomised comparative studies of 309, 510, 169 and 122 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 to 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 to abdominal hysterectomy (8% [14/169] vs 12% [19/162]) (p = 0.39). Significantly fewer postoperative complications associated with laparoscopic compared to abdominal hysterectomy were reported in the same study (17% [27/158] vs 32% [50/155]) (p = 0.007).

2.4.4  The RCT of 2616 patients and 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 less than 1% (1/165 and 1/144 respectively) of patients in both groups.

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 considered an anecdotal adverse event to be dehiscence of the vaginal vault after laparoscopic suturing.

3    Further information

3.1  For related NICE guidance see www.nice.org.uk

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee
April 2010

_{Personal data will not be posted on the NICE website. In accordance with the Data Protection Act names will be anonymised, other than in circumstances where explicit permission has been given.}

 _{It is the responsibility of consultees to accurately cite academic work in order that they can be validated.}