The National Institute for Clinical Excellence is examining laparoscopic transperitoneal simple nephrectomy and will publish guidance on its safety and efficacy to the NHS in England and Wales. 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 transperitoneal simple nephrectomy.

This document has been prepared for public consultation. It summarises the procedure and sets out the provisional recommendations made by the Advisory Committee.

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 the Final Interventional Procedure Document (FIPD) and submit it to the Institute.
• The FIPD may be used as the basis for the Institute's guidance on the use of the procedure in the NHS in England and Wales.

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

Closing date for comments: 27 January 2003

Target date for publication of guidance: April 2004

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

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

Kidneys from live donors are considered more likely to be successful in treating end-stage renal disease than those from cadaver donors.

The standard technique for harvesting kidneys from live donors is by open surgery. The aim of laparoscopic nephrectomy is to reduce donor morbidity and make the process more appealing to potential donors. It can be performed via a transperitoneal or retroperitoneal approach. The transperitoneal approach is preferred because it allows more laparoscopic working space, it makes it easier to remove the kidney and the incision is less painful.

The procedure involves the insertion of laparoscopic instruments through the abdominal wall via a small incision, insufflation of carbon dioxide and removal of a kidney, usually that on the left side.

No difference between the laparoscopic and open procedures was detected for recipient early and late graft function, graft survival or recipient survival, although there was a lack of long-term follow-up data. One study found recipient acute rejection in the first month to be 30% (33/110) for the laparoscopic procedure and 32% (15/48) for the open procedure. Donor hospital stay was generally shorter for the laparoscopic procedure; means ranged from 1.3-3.2 days for the laparoscopic, and 4.1-4.4 days for the open procedure. Laparoscopic donors generally returned to work earlier than donors undergoing the open procedure; means ranged from 2.1-3.9 weeks for the laparoscopic, and 4.1-7.4 weeks for the open procedure. For more details, refer to the sources of evidence (see Appendix).

The Specialist Advisors did not raise any concerns regarding the efficacy of this procedure.

The risks of laparoscopic live donor simple nephrectomy appeared similar to those of open live donor nephrectomy, although numbers of individual complications were small for both procedures, and some studies did not report their open nephrectomy results for comparison. Recipient complications also appeared to be similar for both open and laparoscopic procedures, but these were even less often reported than the donor complications. Recipient ureteric complications were more common for open procedures in one study and less common in another study, while in a third study, there were no ureteric complications in either laparoscopic or open recipients. For more details, refer to the sources of evidence (see Appendix).

The Specialist Advisors considered the main safety concerns to be bleeding, injury to nearby organs and conversion to open surgery.

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 live donor simple nephrectomy, November 2002

Available from: www.nice.org.uk/ip056overview