The National Institute for Clinical Excellence is examining laparoscopic pyeloplasty 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 pyeloplasty.

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: 23 December 2003

Target date for publication of guidance: March 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 on the safety and efficacy of laparoscopic pyeloplasty appears adequate for this procedure to be used, provided that the normal arrangements are in place for consent, audit and clinical governance.

Special training is required to perform the procedure. NICE has asked the British Association of Urological Surgeons to produce standards for training.

Ureteropelvic junction (UPJ) obstruction occurs when the connection between the renal pelvis and the ureter is narrow or tight. When this occurs, urine passing from the kidney to the ureter will not drain easily and accumulates, causing enlargement of the renal pelvis (hydronephrosis).

The standard intervention for UPJ obstruction is open pyeloplasty. There are several different ways to approach the kidney to perform the operation. These may include via a flank incision, a subcostal incision, a transabdominal approach, or an incision in the back.

The purpose of the procedure is to remove the strictured portion of the UPJ, re-fashion the renal pelvis, and attach it to the ureter in a way that allows easy drainage of urine down the ureter. This procedure has the same goal as open pyeloplasty but uses a laparoscopic approach. Instead of a standard incision in the flank, laparoscopy involves making three or four small incisions through which the operation is carried out.

No randomised studies were identified. One of the non-randomised, comparative studies looking at laparoscopic versus open pyeloplasty found that 41 (98%) of the 42 patients who had the laparoscopic procedure had no obstruction at follow-up, compared with 33 (94%) of the 35 patients who had the open procedure. Of the 42 patients treated laparoscopically, 26 (62%) were pain-free and 12 (29%) had a significant reduction in flank pain postoperatively. Of the 35 patients having the open procedure, 21 (60%) were pain-free and 11 (31%) had a significant reduction in flank pain postoperatively. For more details, refer to the sources of evidence (see Appendix).

The Specialist Advisors expressed no concerns about the efficacy of this procedure. One Advisor, however, commented on the lack of randomised comparisons of open versus laparoscopic procedures, and a scarcity of long-term follow-up data.

Relatively few complications were reported in the studies identified. In some comparative studies obstruction after stent removal, stent migration and pyelonephritis were reported as occasional complications, however these complications were reported at similar levels in patients having open surgery. One of the main safety concerns was the increased length of operating time taken to perform laparoscopic pyeloplasty. The mean operating time for the laparoscopic approach ranged from 165 to 356 minutes, compared with between 145 minutes and 228 for open surgery. For more details, refer to the sources of evidence (see Appendix).

One Specialist Advisor commented that the risks of this procedure are similar to those expected with conventional open surgery: infection, failure to correct obstruction and bleeding. This Advisor also noted the usual safety issues associated with laparoscopic surgery applied, as well as the effects of a prolonged procedure, and the need to convert to open surgery.

The Advisory Committee noted that the procedure can be lengthy (see 2.4.1)

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

• Interventional Procedure Overview of Laparoscopic pyeloplasty, November 2002

Available from: www.nice.org.uk/ip050overview