2 The procedure

2.1 Indications and current treatments

2.1.1

Indications for nephrectomy (including nephroureterectomy) include benign and malignant tumours; conditions that damage renal function such as chronic infection; and donation for transplantation. For these indications, other procedures that can be performed through a single port include partial nephrectomy and needle cryoablative therapy.

2.2 Outline of the procedure

2.2.1

Single-port laparoscopic nephrectomy aims to reduce pain and recovery time, and to improve cosmesis, compared with standard laparoscopic nephrectomy.

2.2.2

Single-port laparoscopic nephrectomy is performed with the patient under general anaesthesia, usually using a transperitoneal approach. A single umbilical skin incision is used to insert multiple instruments, typically via a specially designed system. Following laparoscopic dissection, the kidney is usually enclosed in a retrieval bag and removed through the umbilicus or vagina, either intact or morcellated.

2.3 Efficacy

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.

2.3.1

A randomised controlled trial of 50 renal donors treated by single-port laparoscopic donor nephrectomy or standard laparoscopic donor nephrectomy reported significantly lower pain scores (on a visual analogue scale of 1 to 10) of 1.24 and 2.08 respectively at 96 postoperative hours (p=0.0004).

2.3.2

A non-randomised comparative study of 57 patients treated by single-port or conventional laparoscopic nephrectomy reported no significant difference in analgesic use (40 mg versus 45 mg of pethidine), although the pain score was significantly lower on postoperative days 1 to 3 for patients in the single-port group (4.7, 3.4 and 2.7 versus 5.8, 4.6 and 4.0, respectively [p=0.001, p<0.001 and p=0.008]).

2.3.3

A randomised controlled trial of 27 patients treated by single-port or conventional laparoscopic nephrectomy reported a return to normal activities within 11 days and 14 days respectively (p=0.001). A non-randomised comparative study of 35 patients reported a faster return to work and shorter time to complete physical recovery for patients in the single-port group compared with those who had conventional laparoscopic nephrectomy (18 days versus 46 days, p=0.0009, and 29 days versus 83 days, p=0.03, respectively).

2.3.4

The Specialist Advisers listed key efficacy outcomes as improved cosmesis, and, when treating cancer, no new or recurrent cancer.

2.4 Safety

2.4.1

Allograft thrombosis was reported in 1 patient in a non-randomised comparative study including 17 single-port laparoscopic donor nephrectomies: the recipient underwent an allograft nephrectomy after 1 week.

2.4.2

A case series of 18 patients reported 1 bowel injury and 1 diaphragm injury, both of which were repaired without the need for additional ports.

2.4.3

A case series of 62 patients reported that 1 single-port laparoscopic simple nephrectomy was converted to conventional laparoscopy to aid in dissection and 1 single-port nephroureterectomy was converted to conventional laparoscopy to control bleeding.

2.4.4

A case series of 12 patients reported that 1 single-port procedure was converted to conventional laparoscopy because of adhesions and bleeding (requiring blood transfusion). Two single-port laparoscopic nephroureterectomies were converted to open surgery, 1 for complete renal hilar lymphadenectomy and the other for severe adhesions.

2.4.5

In a case series of 15 patients, 1 patient who had bilateral nephrectomy developed severe abdominal distension and dehiscence of the umbilical extraction site. The authors noted that the patient had multiple comorbidities and was on chronic steroid therapy. Postoperative small bowel obstruction was reported in 1 patient 14 days after an uncomplicated single-port procedure: this required surgical exploration.

2.4.6

The Specialist Advisers considered theoretical adverse events to include injury to the great vessels and to adjacent organs including the spleen.

2.5 Other comments

2.5.1

The Committee noted that the technology used for this procedure is evolving rapidly and these developments may influence its safety and efficacy.

2.5.2

The Committee noted that warm ischaemia time may be longer than with standard laparoscopic nephrectomy when using this procedure to harvest kidneys from live donors for transplantation, but any clinical effect of this is uncertain.