The National Institute for Clinical Excellence is examining laparoscopic nephrectomy and will publish guidance on its safety and efficacy to the NHS in England, Wales and Scotland. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisors, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about laparoscopic nephrectomy.

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:

• comments on the preliminary recommendation
• the identification of factual inaccuracies
• additional relevant evidence.

Note that this document is not the Institute's formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that the Institute will follow after the consultation period ends is as follows:

• The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
• The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales and Scotland.

For further details, see the Interventional Procedures Programme manual, which is available from the Institute's website (www.nice.org.uk/ipprogrammemanual).

Closing date for comments: 22 February 2005
Target date for publication of guidance: May 2005

Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.

Current evidence on the safety and efficacy of laparoscopic nephrectomy appears adequate to support the use of this procedure provided that the normal arrangements are in place for consent, audit and clinical governance.

Patient selection is important when this procedure is being considered for the treatment of malignant disease. Further follow-up data are desirable for patients with malignant disease.

Indications for nephrectomy include renal cancer, and benign disease such as symptomatic hydronephrosis, chronic infection, polycystic kidney disease, shrunken kidney, hypertension and renal calculus.

The standard treatment for an irreversibly damaged kidney or localised kidney cancer is an open nephrectomy. Under general anaesthesia, the kidney is removed through an incision in the loin or the front of the abdomen.

A transperitoneal or retroperitoneal approach may be used for laparoscopic nephrectomy. 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 the balloon is removed, the space is insufflated with carbon dioxide and two or three additional small incisions are made in the back. The kidney is freed by laparoscopic dissection. It is then enclosed in a bag and removed through an appropriate incision or placed in an impermeable sac, morcellated and removed through one of the port sites.

One non-randomised comparative study of 100 patients with renal cell carcinoma reported that there was no statistically significant difference in the estimated 5-year disease-free survival rate for laparoscopic and open nephrectomy (95.5% versus 97.5%). A case series of 157 patients with renal cell carcinoma reported an estimated 5-year disease-free survival rate of 91%.

Two non-randomised comparative studies found that significantly less analgesia was required after laparoscopic nephrectomy than after open surgery. In a further two non-randomised comparative studies, the mean hospital stay ranged from 5.2 to 8.9 days for open surgery, compared with 3.4 days to 6.8 days for laparoscopic surgery (p < 0.001). In one study, the mean convalescence period was also significantly shorter for laparoscopic surgery: 23 days compared with 57 days for open surgery (p < 0.001). For more details, refer to the sources of evidence.

Three non-randomised comparative studies reported complication rates for laparoscopic nephrectomy that were not significantly different from those for open nephrectomy. Six studies reported rates of conversion to open surgery: this occurred in 0% (0/54) to 10% (46/482) of procedures.

The complications reported in a large case series of 482 procedures (461 patients) included bleeding in 5% (22/482), re-intervention in 3% (15/482), and bowel injury in less than 1% (3/481). Other complications reported in the studies included: paralytic ileus in 3% of patients (2/60); injury to arteries in 3% (2/60), the spleen in 2% (1/60), and the adrenal gland in 2% (1/60); and urinary tract infection in 1% (2/157). Two case series reported mortality rates of 0.7% (2/263) and 1% (2/157). For more details, refer to the sources of evidence.

The Specialist Advisors stated that potential adverse events included major haemorrhage from renal vessels, bowel injury and the need for conversion to open surgery.

Other comments

The Committee noted that training and competence in laparoscopic techniques were important for surgeons undertaking this procedure.

Further information

The Institute has produced guidance on laparoscopic live donor simple nephrectomy, and this is available from the website (www.nice.org.uk/IPG057guidance)

The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.

Interventional procedure overview of laparoscopic nephrectomy, October 2004

Available from: www.nice.org.uk/ip277overview