Laparoscopic cystectomy

# Guidance
This document replaces previous guidance on laparoscopic cystectomy (Interventional Procedure Guidance 26).
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.
Patient selection for laparoscopic cystectomy should involve a multidisciplinary team experienced in the management of bladder cancer.
Clinicians undertaking laparoscopic cystectomy should have special training. The British Association of Urological Surgeons (BAUS) has produced training standards.
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.# The procedure

# Indications and current treatments
For most bladder cancer patients, the treatment will depend on whether or not the tumour has invaded the bladder's muscular layer. Tumours invading the muscular layer (as well as some 'high-risk', non-invading tumours) are usually treated by radical cystectomy or radiotherapy. When radical cystectomy is used reconstructive surgery is also required. Laparoscopic cystectomy is an alternative to radical cystectomy by open surgery.

# Outline of the procedure
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 a laparoscope and surgical instruments. The ureters are isolated, ligated and divided and the vascular pedicles to the bladder are ligated, transected and stapled.
In men the prostate and seminal vesicles are dissected and removed with the bladder, and retrieved through an abdominal incision. In women, depending on the tumour burden and stage, the uterus and part of the vagina may need to be removed. Sometimes the ovaries are also removed.
Urinary diversion or formation of a neo bladder can be done laparoscopically or, more commonly, by an open procedure.
There are various ways of carrying out laparoscopic cystectomy and the procedure may be performed with computer (robotic) assistance.
Sections 2.3 and 2.4 describe efficacy and safety outcomes which were available in the published literature and which the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview.

# Efficacy
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 19.5 months and 19 months, respectively (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.
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).
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, histology clear 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.

# Safety
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.
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 included abdominal abscess (8% ), percutaneous drainage of abscess (3% ), injury to artery (1% ), urinary leakage (1% ), urinary tract infection (10% ) and haematoma (4% ).
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.
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.

# Other comments
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).
The Committee noted that most surgeons had stopped doing bladder reconstruction laparoscopically as part of this procedure.# Further information
NICE has issued cancer service guidance on urological cancers.

# 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.# About this guidance
NICE interventional procedure 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. It is for healthcare professionals and people using the NHS in England, Wales, Scotland and Northern Ireland, and is endorsed by Healthcare Improvement Scotland for implementation by NHSScotland.
This guidance was developed using the NICE interventional procedure guidance process.
It updates and replaces NICE interventional procedure guidance 26.
We have produced a summary of this guidance for patients and carers. Information about the evidence it is based on is also available.
Changes since publication
January 2012: minor maintenance.
Your responsibility
This guidance represents the views of NICE and was arrived at after careful consideration of the available evidence. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. This guidance does not, however, override the individual responsibility of healthcare professionals to make 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 responsibility of local commissioners and/or providers. Commissioners and providers are reminded that it is their responsibility to implement the guidance, in their local context, in light of their duties to avoid unlawful discrimination and to have regard to promoting equality of opportunity. Nothing in this guidance should be interpreted in a way which would be inconsistent with compliance with those duties.
Copyright
 National Institute for Health and Clinical Excellence 2009. All rights reserved. NICE copyright material can be downloaded for private research and study, and may be reproduced for educational and not-for-profit purposes. No reproduction by or for commercial organisations, or for commercial purposes, is allowed without the written permission of NICE.
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