A peritoneal dialysis catheter is a soft tube that is inserted into the abdomen in order to remove waste products from the blood (normally removed by the kidneys). Laparoscopic insertion - also known as 'keyhole surgery' - is a way of inserting the catheter using a fine telescope to guide the catheter into the abdominal cavity.

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

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 recommendations
  
• 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• The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.

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: 28 November 2006
Target date for publication of guidance: February 2007

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 insertion of peritoneal dialysis catheter appears adequate to support the use of this procedure provided that the normal arrangements are in place for consent, audit and clinical governance.

Clinicians should ensure that patients understand the potential risks and benefits of the procedure, and the alternatives. Clinicians should provide patients with clear written information. In addition, use of the Institute's information for patients ('Understanding NICE guidance') is recommended (available from www.nice.org.uk/IPGXXXpublicinfo). [[details to be completed at publication]]

The evidence on the selection of patients for this technique of peritoneal dialysis catheter insertion is unclear. Publication of further relevant evidence will be useful in guiding clinical practice.

Peritoneal dialysis is an alternative to haemodialysis and is used to treat patients with end-stage renal disease. It involves infusing fluid into the peritoneal cavity via a catheter and leaving it there for sufficient time to allow metabolic waste products to diffuse through the peritoneal membrane into the dialysis fluid, which is then drained away.

A peritoneal dialysis catheter is conventionally inserted through a small incision in the abdomen, under local or general anaesthesia. The catheter is directed towards the pelvis, which is the best place for the tip to lie. The catheter can also be placed using a percutaneous technique.

A randomised controlled trial reported that 57% (12/21) of catheters inserted laparoscopically and 54% (13/24) of catheters inserted via an open incision were still in use after a median follow-up of 18.5 months (p value not stated).

A non-randomised controlled trial of 42 patients reported catheter survival at 12 months to be 91% in the laparoscopic group and 71% in the open-insertion group (p = 0.019). A second non-randomised controlled trial reported revision-free catheter survival probabilities at 1, 2 and 3 years to be significantly higher after laparoscopic insertion than after open insertion: 87%, 81% and 76%, respectively, after laparoscopic insertion (n = 150) compared with 74%, 57% and 39%, respectively, after open insertion (n = 63) (p < 0.001).="" a="" third="" non-randomised="" controlled="" trial="" of="" 102="" patients="" reported="" catheter="" survival="" at="" 1,="" 2="" and="" 3="" years="" to="" be="" 79%,="" 53%="" and="" 37%,="" respectively="" in="" the="" laparoscopic="" group,="" compared="" with="" 65%,="" 43%="" and="" 29%,="" respectively,="" in="" the="" open-insertion="" group="" (the="" differences="" were="" not="" statistically="" significant).="" another="" non-randomised="" controlled="" trial="" reported="" that="" 70%="" (16/23)="" of="" catheters="" inserted="" laparoscopically="" were="" still="" functioning="" at="" the="" end="" of="" the="" study="" (follow-up="" period="" not="" stated)="" compared="" with="" 40%="" (8/20)="" of="" catheters="" inserted="" using="" a="" single="" trocar="" peritoneoscopic="" technique="" (p="" value="" not="">

The Specialist Advisers did not note any concerns about the efficacy of the procedure.

The randomised controlled trial reported that 29% (6/21) of patients in the laparoscopic-insertion group had peritonitis more than 6 weeks after catheter insertion, compared with 46% (11/24) of patients in the open-insertion group (p value not stated). One non-randomised controlled trial reported similar rates of peritonitis after laparoscopic and open insertion (32% [16/50] versus 25% [13/52] after mean follow-ups of 26 and 19 months, respectively). Another non-randomised controlled trial reported a significantly lower rate of peritonitis after laparoscopic insertion than after open insertion more than 4 weeks after the procedure (5% [1/21] versus 14% [3/21], p <>

In the randomised controlled trial, exit-site infections more than 6 weeks after catheter insertion were reported in 29% (6/21) of patients in the laparoscopic-insertion group compared with 17% (4/24) of patients in the open-insertion group (p value not stated).Two non-randomised controlled trials reported exit-site infections more than 4 weeks after the procedure in 5% (1/21) and 6% (3/50) of laparoscopic procedures compared with 10% (2/21) and 10% (5/52) of open procedures, respectively (p values not significant). One large case series reported recurrent peritonitis or exit-site infection after 18% (26/148) of laparoscopic procedures.

Two non-randomised controlled trials reported that 14% (3/21) and 12% (3/25) of patients in the laparoscopic groups needed surgical revision, compared with 38% (8/21) and 17% (4/23) of patients in the open-surgery groups (p values not stated). Two case series of laparoscopic insertion reported surgical revision rates of 20% (25/123) and 24% (8/34).

Eight studies reported catheter leakage rates ranging from 0% (0/25) to 10% (2/21) of laparoscopic procedures. Five studies reported catheter blockage rates ranging from 0.5% (1/200) to 29% (10/34) of laparoscopic procedures.

Two non-randomised controlled trials and one case series reported peri- or postoperative haemorrhage in 0% (0/200), 2% (1/50) and 5% (7/148) of laparoscopic procedures. Another case series of 34 patients reported that one patient died of haemorrhage 6 days after surgery, having resumed oral anticoagulation treatment immediately after the procedure.

The Specialist Advisers listed potential adverse events as bowel perforation, fluid leaks, infection, catheter migration or blockage, and bleeding. Two advisers noted that potential adverse events were mainly those associated with laparoscopic surgery per se. Other adverse events occur with both laparoscopic and open procedures for catheter insertion.

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 insertion of peritoneal dialysis catheter', July 2006.