Interventional procedures consultation document - laparoscopic cystectomy
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE
Interventional Procedure Consultation Document
Laparoscopic cystectomy
| Laparoscopic cystectomy involves removing the bladder using small cuts (also known as 'keyhole surgery'). In women, the bladder is removed through the wall of the vagina. In men, the bladder is removed with the prostate gland, through a small cut in the wall of the abdomen. The tubes that carry urine from the kidneys to the bladder (the ureters) may then be connected to a bag worn outside the body, or parts of the bowel can be used to make an artificial bladder which is drained by a connection to the abdomen wall or to the tube that carries urine out of the body (the urethra). |
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The National Institute for Health and Clinical Excellence (NICE) is examining laparoscopic cystectomy 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 cystectomy. 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:
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.
For further details, see the Interventional Procedures Programme manual, which is available from our 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 We also ask consultees to highlight any ways in which draft guidance fails to promote equality or tackle discrimination and give suggestions for how it might be improved. Closing date for comments: 25 November 2008 Target date for publication of guidance: February 2009 |
| Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation. |
| 1 | Provisional recommendations |
| 1.1 | Current evidence on the safety and efficacy of laparoscopic cystectomy appears 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 cystectomy should involve a multidisciplinary team experienced in the management of bladder cancer. |
| 1.3 | Clinicians undertaking laparoscopic cystectomy should have special training. The British Association of Urological Surgeons (BAUS) has produced training standards. |
| 1.4 | Clinicians should submit data on all patients undergoing this procedure to the BAUS Cancer Registry & Sections Audit with a view to further publication on long-term survival outcomes (www.baus.org.uk/baus_subspecialty_sections/baus_cancer_registry__sections_audit.phtml). |
| 2 | The procedure |
| 2.1 | Indications and current treatments |
| 2.1.1 | Laparoscopic cystectomy is an alternative to radical cystectomy by open surgery. The main indication for laparoscopic cystectomy is invasive bladder cancer, in which cancer invades the muscular layer of the bladder (stages T2 and T3). The intention of laparoscopic cystectomy is to prevent the spread of cancer to the other organs of the pelvis (stage T4). |
| 2.1.2 | The treatment for bladder cancer depends on the type, stage and grade of cancer, but usually involves surgery or radiotherapy. When radical cystectomy is used, a method of urinary diversion is also required. |
| 2.2 | Outline of the procedure |
| 2.2.1 | Laparoscopic cystectomy is carried out with the patient under general anaesthesia. The abdomen is insufflated with carbon dioxide and small incisions are made to allow the introduction of laparoscope and surgical instruments. The ureters are isolated, ligated and divided and the vascular pedicles to the bladder are ligated, transected and stapled. |
| 2.2.2 | In men the prostate and seminal vesicles are dissected and removed with the bladder; they are retrieved through an abdominal incision. In women, the bladder is extracted through the wall of the vagina. Depending on the tumour burden and stage, the uterus and part of the vagina may need to be taken out with the bladder. Sometimes the ovaries are also removed. |
| 2.2.3 | Urinary diversion can be done laparoscopically or by an open procedure, the latter being more common. |
| 2.2.4 | There are various ways of carrying out laparoscopic cystectomy. |
| 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/IP115overview. | |
| 2.3 | Efficacy |
| 2.3.1 | A non-randomised comparative study of 65 patients reported a recurrence-free survival of 77% (23/30) for laparoscopic cystectomy compared with 80% (28/35) for open cystectomy at mean follow-up periods of 38 months and 46 months respectively; (p = 0.2). A non-randomised comparative study of 42 patients reported no disease-related deaths in the 20 patients treated by laparoscopic surgery compared with 5% (1/21) of patients in the open cystectomy group during a mean follow-up of 19 months for the open cystectomy group and 19.5 months for the laparoscopic group (p value not significant). A case series of 84 patients reported a disease-free survival of 83% (70/84) at a mean follow-up of 18 months. |
| 2.3.2 | The study of 65 patients reported a lower mean requirement for analgesia in the laparoscopic group than in the open cystectomy group (32 mg and 65 mg % morphine equivalent, respectively; p = 0.001). The study of 42 patients reported a mean requirement for non-opioid analgesics of 2.2 vials/day in the laparoscopic group compared with 3.9 vials/day in the open cystectomy group (p < 0.05). |
| 2.3.3 | The Specialist Advisers considered that key efficacy outcomes included need for blood transfusion, time to discharge, requirement for analgesia, time to return to full activity, positive margin rates, extent of lymph node dissection and cancer‑specific 5-year survival. One stated that the procedure has not been performed for long enough or in sufficient numbers to be able to evaluate the incidence of local recurrence of cancer or subsequent metastases. |
| 2.4 | Safety |
| 2.4.1 | Conversion to open surgery was reported in 5% (1/20) and 3% (1/33) of patients in two non-randomised controlled trials, and 0% (0/84) and 2% (2/83) in two case series. |
| 2.4.2 | Fistulae (including vaginal, urinary and enterovesical) were reported in 1% (1/83), 2% (2/84), 3% (1/33) and 8% (1/13) of patients in the two case series of 83 and 84 patients, the non-randomised controlled trial of 54 patients comparing open cystectomy with robotically assisted cystectomies, and a further non-randomised controlled trial of 37 patients, respectively. Rectal injury was reported in 5% (1/20) and 3% (1/30) of patients in the non-randomised controlled trials of 44 and 65 patients, respectively. Other complications reported in the studies included abdominal abscess (8% [1/13]), percutaneous drainage of abscess (3% [1/33]), injury to artery (1% [1/84]), urinary leakage (1% [1/83]), urinary tract infection (10% [8/84]) and haematoma (4% [3/84]). |
| 2.4.3 | There was a case report of port site metastasis in a patient 10 months after laparoscopic cystectomy; the patient was reported to have high-grade high-stage transitional cell carcinoma. |
| 2.4.4 | One Specialist Adviser considered that theoretical adverse events included difficulty controlling haemorrhage, bowel injury or obstruction, inadequate cancer clearance and port site metastasis. The Specialist Advisers stated that anecdotal adverse events include bowel fistula, peritonitis and prolonged operative time. One Adviser stated that the laparoscopic technique may not allow as radical an excision as open surgery, particularly for lymph nodes. |
| 2.5 | Other comments |
| 2.5.1 | The Committee noted that the published evidence on laparoscopic cystectomy was in patients with bladder cancer. There may be other patients for whom the procedure might be beneficial: they should be referred by the specialist teams caring for them to units with experience in case selection and use of laparoscopic cystectomy (see 1.2 and 1.3). |
| 2.5.2 | The Committee noted that most surgeons had stopped doing bladder reconstruction laparoscopically as part of this procedure. |
| 3 | Further information |
| 3.1 | NICE has issued Cancer service guidance on urological cancers (www.nice.org.uk/nicemedia/pdf/Urological_Manual.pdf). |
Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
September 2008
This page was last updated: 30 March 2010