Laparoscopic nephrolithotomy and pyelolithotomy: consultation
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE
Interventional Procedure Consultation Document
Laparoscopic nephrolithotomy and pyelolithotomy
Renal (kidney) stones can form in one or both kidneys. In laparoscopic nephrolithotomy and pyelolithotomy, small incisions are made in the abdomen and the stones are removed from the kidney using a fine fibreoptic tube to see and perform simple movements inside the body (also known as ‘keyhole surgery’). |
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The National Institute for Health and Clinical Excellence is examining laparoscopic nephrolithotomy and pyelolithotomy 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 nephrolithotomy and pyelolithotomy. 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:
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 The Advisory Committee will then prepare draft guidance which will be the basis for the Institute’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.
Closing date for comments: 19 December 2006 |
Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation. |
| 1 | Provisional recommendations |
| 1.1 | Limited evidence suggests that laparoscopic nephrolithotomy and pyelolithotomy are safe and efficacious enough to support their use provided that normal arrangements are in place for consent, audit and clinical governance |
| 1.2 | These procedures should only be performed by surgeons working within a multidisciplinary team experienced in the management of renal stones, and who have advanced laparoscopic skills. |
| 1.3 | More information about case selection criteria would be useful. |
| 2 | The procedure |
| 2.1 | Indications |
| 2.1.1 | Renal stones are hard masses that form from crystals in urine. They range in size from small gravel-like stones to large stones that extend into more than one calyx (staghorn calculi). Although kidney stones are often asymptomatic, they can cause pain in the abdomen, lower back or groin, and blood in the urine. Depending on its size and position, an untreated stone can obstruct the passage of urine or lead to infection and permanent kidney damage |
| 2.1.2 | Small renal stones will usually pass out of the kidney in the urine without any treatment. However, larger stones and those that cause persistent symptoms may need to be broken into smaller pieces or removed. A variety of techniques are available, depending on the number and size of stones, and their site and type. These techniques include open surgery, percutaneous nephrolithotomy (PCNL), ureteroscopic techniques, and extracorporeal shockwave lithotripsy. |
| 2.2 | Outline of the procedure |
| 2.2.1 | Laparoscopic nephrolithotomy and pyelolithotomy are similar procedures, performed under general anaesthesia, using a transperitoneal or retroperitoneal approach. |
| 2.2.2 | The abdomen is insufflated with an inert gas and small incisions are made to allow insertion of instruments. In laparoscopic nephrolithotomy, incisions are made in the renal capsule and parenchyma (nephrotomy) and the stone or stones are removed from the affected calices. The nephrotomy site may or may not be closed with sutures, and a stent running from the kidney to the bladder may be inserted and left in place for several weeks after surgery. In pyelolithotomy, the stone is removed via an incision in the renal pelvis (pyelotomy), which is usually then closed with sutures, with or without insertion of a stent. A recent development is the use of laparoscopic assistance to perform PCNL. |
| 2.3 | Efficacy |
| 2.3.1 | Two non-randomised controlled trials reported that similar proportions of patients were stone-free after laparoscopic pyelolithotomy and PCNL (88% [14/16] versus 81% [13/16], respectively, in one trial; 100% in both groups [16/16 and 12/12] in the other). A third non-randomised controlled trial of 89 patients reported that none of those treated with laparoscopic pyelolithotomy had residual stones, compared with 13% of patients treated with PCNL. One case series reported that all 15 patients were stone-free after the procedure; in another case series, 6/7 patients were stone-free after treatment. In a third case series, all 8 patients were stone-free 3 months after laparoscopic pyelolithotomy; 7 were still stone-free at 12 months’ follow-up. |
| 2.3.2 | The three non-randomised controlled trials (149 patients in total) reported mean lengths of hospital stay of 3.9, 6.5 and 3.8 days for laparoscopic pyelolithotomy, compared with 5.4, 5.6 and 3.0 days for PCNL (p = 0.17 in one study; p values were not reported in the other studies). Two of the non-randomised controlled trials reported that the mean time to return to normal activities was 13 days after laparoscopic pyelolithotomy (both studies), compared with 14 and 10 days after PCNL (p value not reported; not significant, respectively). |
| 2.3.3 | The Specialist Advisers noted that these procedures are likely to be suitable for a small proportion of patients with renal stones. They also noted that experience in stone management and special training in laparoscopic surgery are necessary. |
| 2.4 | Safety |
| 2.4.1 | Two non-randomised controlled trials reported peritoneal tears in 12% (5/43) and 19% (3/16) of patients treated with laparoscopic pyelolithotomy using a retroperitoneal approach, but in none of the patients treated with PCNL. Peritoneal tears may lead to a requirement for open conversion, due to loss of operative space. Open conversion was required in 1 of the 8 such reported cases in these two studies. Three studies reported urinary leakage (not further defined) in 7% (1/15), 10% (2/20) and 13% (2/16) of patients treated laparoscopically. |
| 2.4.2 | Three non-randomised controlled trials reported that 13–16% of laparoscopic pyelolithotomy procedures (7/43 and 2/16 in two separate studies) had to be converted to open surgery, compared with 0–2% of percutaneous procedures (1/48, 0/16, 0/12). In one case series, none of eight laparoscopic procedures required conversion to open surgery; in another, 20% (4/20) were converted to open surgery. |
| 2.4.3 | The Specialist Advisers listed potential adverse events as the need for nephrectomy or conversion to open surgery, urinary fistula, urinary leakage, haemorrhage and infection. |
| 2.5 | Other comments |
| 2.5.1 | It was noted that procedures of this kind are seldom needed, as most renal stones can be managed in other ways. The fact that these technically advanced procedures are likely to be used infrequently underpins the recommendation in section 1.2. |
| 3 | Further information |
| 3.1 | This guidance requires that clinicians undertaking the procedure make special arrangements for audit. The Institute has identified relevant audit criteria and is developing an audit tool (which is for use at local discretion), which will be available when the guidance is published. |
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Bruce Campbell |
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Chairman, Interventional Procedures Advisory Committee |
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December 2006 |
| Appendix: Sources of evidence |
| The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations. ‘Interventional procedures overview of laparoscopic nephrolithotomy and pyelolithotomy’, August 2006. Available from: www.nice.org.uk/ip364overview. |
This page was last updated: 30 March 2010