2 The procedure

2.1 Indications

2.1.1 Indications for laparoscopic partial nephrectomy include: a solid renal tumour in a patient with a solitary kidney or compromised contralateral kidney; bilateral renal tumours; and small localised renal tumours in patients with a normal contralateral kidney. Most solid renal tumours are renal cell carcinomas but a small proportion of them are benign tumours, such as oncocytomas. The standard treatment for renal tumours is open partial nephrectomy.

2.1.2 Some small tumours may not be suitable for laparoscopic partial nephrectomy because of their position (centrally located lesions are more difficult to remove than peripheral lesions).

2.2 Outline of the procedure

2.2.1 A laparoscopic partial nephrectomy is performed under general anaesthetic, using a transperitoneal or retroperitoneal approach. In the transperitoneal approach, the abdomen is insufflated with carbon dioxide and three or four small abdominal incisions are made. In the retroperitoneal approach, a small incision is made in the back and a dissecting balloon is inserted to create a retroperitoneal space. After insufflation with carbon dioxide, two or three additional small incisions are made in the back. The renal vessels are identified and either controlled using vessel loops or clamped, and the kidney is mobilised to allow exposure of the lesion. A laparoscopic ultrasound probe may be used to determine the line of incision and depth of tumour involvement. The specimen is enclosed in a bag and retrieved through an expanded port.

2.2.2 Hand-assisted laparoscopic partial nephrectomy allows the surgeon to place one hand in the abdomen while maintaining the pneumoperitoneum required for laparoscopy. An additional small incision is made that is just large enough for the surgeon's hand, and an airtight 'sleeve' device is used to form a seal around the incision.

2.3 Efficacy

2.3.1 One non-randomised comparative study of 200 patients reported a median hospital stay of 2 days for laparoscopic partial nephrectomy compared with 5 days for open partial nephrectomy (p < 0.001). A second non-randomised comparative study, which involved 49 patients, reported a mean hospital stay of 3 days for the laparoscopic procedure compared with 6 days for open surgery (p < 0.0002). The first of these studies also reported a significantly shorter median convalescence time for laparoscopic partial nephrectomy compared with open partial nephrectomy (4 weeks versus 6 weeks, p < 0.001).

2.3.2 In one non-randomised comparative study, positive surgical margins (with tumour involvement) were reported after 3% (3/100) of laparoscopic partial nephrectomies compared with 0% (0/100) of open partial nephrectomies. In a second non-randomised comparative study, positive surgical margins were reported in 0% (0/27) of laparoscopic procedures and 5% (1/22) of open procedures. Two case series reported positive surgical margins in 3% (1/37 and 3/100) of cases.

2.3.3 Three studies reported tumour recurrence rates of 0% (0/100), 0% (0/79) and 4% (2/48) after mean follow-up periods of 15 months, 20 months and 38 months, respectively. For more details, refer to the Sources of evidence.

2.3.4 The Specialist Advisors noted concern about the possibility of incomplete cancer clearance.

2.4 Safety

2.4.1 Six studies reported urine leakage as a complication, affecting between 2% (2/100) and 9% (5/53) of patients. In three studies, the rate of postoperative haemorrhage was 2% (4/200, 2/100 and 1/53 of patients), and the rate of intraoperative haemorrhage ranged from 3% (3/100) to 8% (4/53). Other complications included renal failure; damage to the ureter, bowel and blood vessels; and urinary tract infection. For more details, refer to the sources of evidence.

2.4.2 The main safety concerns listed by the Specialist Advisors were intraoperative and postoperative bleeding, and urine leak.

2.5 Other comments

2.5.1 It was noted that the published evidence came from highly specialised units experienced in laparoscopic renal surgery, where clinicians have undertaken a large number of laparoscopic partial nephrectomies.

Andrew Dillon
Chief Executive
January 2006