Laparoscopic radical hysterectomy for early stage cervical cancer - Consultation Document

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

Interventional procedure consultation document

Laparoscopic radical hysterectomy for early stage cervical cancer

Hysterectomy is the cervical removal of the uterus. When a hysterectomy is used to treat cervical cancer, many of the structures connected to the uterus also need to be removed. This is known as a radical hysterectomy. A laparoscopic radical 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 radical hysterectomy for early stage cervical 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 radical hysterectomy for early stage cervical 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  • The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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: 27 January 2010

Target date for publication of guidance: April 2010

 

1       Provisional recommendations

1.1  Current evidence on the efficacy and safety of laparoscopic radical hysterectomy for early stage cervical 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 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 radical hysterectomy for early stage cervical cancer.

2       The procedure

2.1    Indications and current treatments

2.1.1  Cervical cancer is the second most common cancer in women under 35 years in the UK. The most common symptoms of cervical cancer are abnormal vaginal bleeding or discharge, and discomfort during intercourse.

2.1.2  The International Federation of Gynecology and Obstetrics (FIGO) staging system is used to define the stages of cervical cancer from stage I to IV. Early stage cervical cancer includes stages I (cancer confined to the cervix) to IIA (tumour invades the cervix with endocervical glandular involvement only).

2.1.3  Early stage cervical cancer is usually treated by radical hysterectomy (also known as Wertheim’s hysterectomy). Radiotherapy may be used, with or without surgery, and may be combined with chemotherapy. More advanced cervical cancer is generally treated with radiotherapy and chemotherapy.

2.2    Outline of the procedure

2.2.1  Laparoscopic radical hysterectomy for early stage cervical cancer is carried out with the patient under general anaesthesia. Several small incisions are made to provide access for the laparoscope and surgical instruments, and 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.

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/IP51aoverview.

 

2.3    Efficacy

2.3.1  A non-randomised comparative study of 102 patients with stage IA–IIB cervical cancer reported 3-year overall survival of 82% for both abdominal and laparoscopic radical hysterectomy.

2.3.2  A non-randomised comparative study of 127 patients with stage IA–IB cervical cancer reported a disease-free survival rate of 92% for laparoscopic radical hysterectomy and 94% for abdominal radical hysterectomy at median follow-up of 53 and 72 months respectively (p = 0.29) (absolute figures not stated).

2.3.3  A case series of 78 patients with stage IA–IB cervical cancer reported an estimated 5-year overall survival rate of 94% (absolute figures not stated).

2.3.4  A non-randomised comparative study of 125 patients with stage IB–IIA cervical cancer reported a recurrence rate of 14% for laparoscopic radical hysterectomy and 12% for abdominal radical hysterectomy, at a median follow-up of 26 months (p > 0.05) (absolute figures not stated).

2.3.5  The non-randomised comparative study of 127 patients reported a significant difference in the mean number of lymph nodes removed in patients treated by laparoscopic radical hysterectomy compared with abdominal radical hysterectomy (23.5 and 25.2 respectively) (p < 0.01).

2.3.6  The non-randomised comparative studies of 102 and 125 patients reported no significant difference in the mean number of pelvic nymph nodes removed between patients treated by laparoscopic radical hysterectomy (11 and 21) and those treated by abdominal radical hysterectomy (12 and 19) (p = 0.8, p > 0.05 respectively).

2.3.7  The Specialist Advisers listed key efficacy outcomes as completion of the procedure without conversion to open surgery, number of lymph nodes removed, shorter recovery time and length of hospital stay, rate of cancer recurrence and 5-year survival.

2.4    Safety

2.4.1  Intraoperative bladder injury during laparoscopic radical hysterectomy and abdominal radical hysterectomy occurred at rates ranging from 1% (3/248 and 1/101) to 6% (3/50), and from 0% (0/35) to 4% (2/48) respectively across the studies.

2.4.2  A case report described complete bladder gangrene 3 weeks after laparoscopic radical hysterectomy in 1 patient. A total cystectomy and cutaneous ureterostomy was performed and the patient recovered fully with no cancer recurrence at 33-month follow-up.

2.4.3  Intraoperative ureteric injury occurred at rates ranging from 0% (0/90) to 2% (1/46 and 1/50) during laparoscopic radical hysterectomy (2 were treated laparoscopically) and from 0% (0/48) to 6% (2/35) during abdominal radical hysterectomy across the studies (no further details given).

2.4.4  Intraoperative bowel injury was reported in 2% (1/46), 1% (2/248; laparoscopically sutured) and 1% (3/295; 2 sutured vaginally and 1 conversion to open surgery) of patients in the non-randomised comparative study of 102, and case series of 248 and 295 patients respectively.

2.4.5  The non-randomised comparative studies of 98 and 125 patients reported ureteric fistula in 2% (1/50; from ischaemic necrosis requiring further open surgery at 14-day follow-up) and 1% (1/90; postoperative, managed conservatively) of patients treated by laparoscopic radical hysterectomy. No ureteric fistulae were reported in the comparator groups treated by abdominal radical hysterectomy. Postoperative ureteric fistula was reported in 5% (5/101) of patients in the case series of 101 patients (1 required ureteral reimplantation, 4 treated with stents; timing of events not stated).

2.4.6  Postoperative vesicovaginal fistula was reported in 1% (1/90) and 2% (1/50) of patients treated by laparoscopic radical hysterectomy compared with no patients treated by abdominal radical hysterectomy in the non-randomised comparative studies of 125 and 98 patients (not otherwise described). The case series of 295 patients reported postoperative vesicovaginal fistula in 1% (4/295) of patients (1 closed by conservative treatment, 3 repaired vaginally or abdominally; timing of events not stated).

2.4.7  Splenic rupture 5 days after laparoscopic radical hysterectomy was reported in a case report; the patient was treated by a splenectomy. 

2.4.8  The Specialist Advisers considered theoretical adverse events to include inadequate lymph node sampling and excision of the primary tumour.  

3     Further information

3.1  This document is a review of the NICE interventional procedures guidance 24 published in 2003. For related NICE guidance see www.nice.org.uk 

Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
December 2009

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

This page was last updated: 19 May 2010