2 The procedure
2.1.1 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.
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 a 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, 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.
2.2.3 Urinary diversion or formation of a neo bladder can be done laparoscopically or, more commonly, by an open procedure.
2.2.4 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.
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 19.5 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.
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, 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.
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 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.
2.5.1 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.