Interventional procedure consultation document

Single-port laparoscopic nephrectomy

Removing a kidney using single-incision keyhole surgery

If a kidney is affected by cancer or irreversibly damaged, it may need to be removed. Removal of a kidney (nephrectomy) can be done as an open operation or through ‘keyhole surgery’ using several small incisions (laparoscopy). This procedure aims to produce less scarring and discomfort than traditional open or laparoscopic nephrectomy, by using a single ‘keyhole’.

The National Institute for Health and Clinical Excellence (NICE) is examining single port laparoscopic nephrectomy and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. NICE’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 single port 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 provisional recommendations
• the identification of factual inaccuracies
• additional relevant evidence, with bibliographic references where possible.

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

The process that NICE 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• The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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 NICE website (www.nice.org.uk/ipprogrammemanual).

Through its guidance NICE is committed to promoting race and disability equality, equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our interventional procedures guidance. In particular, we aim to encourage people and organisations from groups who might not normally comment on our guidance to do so.

In order to help us promote equality through our guidance, we should be grateful if you would consider the following question:

Are there any issues that require special attention in light of NICE’s duties to have due regard to the need to eliminate unlawful discrimination and promote equality and foster good relations between people with a characteristic protected by the equalities legislation and others?

Please note that NICE reserves the right to summarise and edit comments received during consultations or not to publish them at all where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate.

Closing date for comments: 24 June

Target date for publication of guidance: October 2011

1   Provisional recommendations

1.1  Evidence on the safety and efficacy of single-port laparoscopic nephrectomy is based on limited numbers of patients. Any advantage for patients of the procedure over conventional laparoscopic nephrectomy is uncertain and there is inadequate evidence on safety, including insufficient information about warm ischaemia time when used to harvest kidneys from live donors for transplantation. Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit or research.

1.2  Clinicians wishing to undertake single-port laparoscopic nephrectomy should take the following actions.

• Inform the clinical governance leads in their Trusts.
• Ensure that patients understand the uncertainty about the procedure’s safety and efficacy and provide them with clear written information. In addition, the use of NICE’s information for patients (‘Understanding NICE guidance’) is recommended (available from www.nice.org.uk/IPGXXXpublicinfo). [[details to be completed at publication]]
• Audit and review clinical outcomes of all patients having single-port laparoscopic nephrectomy (see section 3.1).

1.3  Patient selection is important when the procedure is being considered for the treatment of patients with malignant disease. Long-term follow-up data are lacking, and clinicians are encouraged to collect and publish data on rates of recurrence in patients treated for renal malignancy.

1.4  Single-port laparoscopic nephrectomy is technically challenging and should only be carried out by experienced laparoscopic surgeons who have received specific training in the procedure.

2   The procedure

2.1  Indications and current treatments

2.1.1  Indications for nephrectomy (including nephroureterectomy) include benign and malignant tumours; conditions that damage renal function such as chronic infection; and donation for transplantation.

2.2   Outline of the procedure

2.2.1  Single-port laparoscopic nephrectomy aims to reduce pain, recovery time and wound complications, and to improve cosmesis, compared with standard laparoscopic nephrectomy.

2.2.2  Single-port laparoscopic nephrectomy is performed with the patient under general anaesthetia, usually via a transperitoneal approach. A single umbilical skin incision is used to insert a specially designed system that enables multiple instruments to be passed. Following laparoscopic dissection the kidney is usually enclosed in a retrieval bag and removed through the umbilicus or vagina, either intact or morcellated.

Sections 2.3 and 2.4 describe efficacy and safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview, available at www.nice.org.uk/guidance/IP/921/overview

2.3   Efficacy

2.3.1  A randomised controlled trial (RCT) of 27 patients treated by single-port laparoscopic nephrectomy or conventional laparoscopic nephrectomy reported that patients required an average of 21 mg and 45 mg of morphine sulphate (or equivalent) for pain relief respectively on postoperative day 2 (p = 0.01). A non-randomised comparative study of 33 patients treated by single-port or conventional laparoscopic nephrectomy reported no significant difference in median analgesic use (8 mg versus 15 mg morphine equivalent, p = 0.6). A non-randomised comparative study of 21 patients treated by single-port or conventional laparoscopic nephrectomy reported no significant difference in mean postoperative analgesia (364 mg versus 231 mg, p = 0.55).

2.3.2  The RCT of 27 patients treated by single-port or conventional laparoscopic nephrectomy reported a return to normal activities within 11 days and 14 days respectively (p = 0.001). A non-randomised comparative study of 35 patients reported a faster return to work and shorter time to complete physical recovery for patients in the single-port group compared with those who had conventional laparoscopic nephrectomy (18 days versus 46 days, p = 0.0009, and 29 days versus 83 days, p = 0.03, respectively).

2.3.3  The non-randomised comparative study of 35 patients treated by single-port or conventional laparoscopic nephrectomy reported mean patient-reported overall satisfaction scores of 9.5 and 8.5 (scale 1–10), respectively (p = 0.053).

2.3.4  The Specialist Advisers listed additional key efficacy outcomes as improved cosmesis, and, when treating cancer, no new or recurrent cancer.

2.4   Safety

2.4.1  Allograft thrombosis was reported in 1 patient in a non-randomised comparative study including 17 single-port laparoscopic donor nephrectomies: the recipient underwent an allograft nephrectomy after 1 week.

2.4.2  A case series of 18 patients reported 1 bowel injury and 1 diaphragm injury, both of which were repaired without the need for additional ports.

2.4.3  A case series of 12 patients reported that 1 single-port procedure was converted to conventional laparoscopy because of adhesions and bleeding (requiring blood transfusion). Two single-port laparoscopic nephroureterectomies were converted to open surgery; 1 for complete renal hilar lymphadenectomy and the other for severe adhesions.

2.4.4  In a case series of 15 patients, 1 patient who had bilateral nephrectomy developed severe abdominal distension and dehiscence of the umbilical extraction site. The authors noted that the patient had multiple comorbidities and was on chronic steroid therapy. Postoperative small bowel obstruction was reported in 1 patient 14 days after an uncomplicated single-port procedure: this required surgical exploration.

2.4.5  A non-randomised comparative study including 19 patients treated by single-port laparoscopic nephrectomy reported 1 wound infection.

2.4.6  The Specialist Advisers considered theoretical adverse events to include injury to the great vessels and to adjacent organs including the duodenum and spleen.

2.5   Other comments

2.5.1  The Committee noted that the technology used for this procedure is evolving rapidly and these developments may influence its safety and efficacy.

2.5.2  The Committee noted that warm ischaemia time may be longer than with standard laparoscopic nephrectomy when using this procedure to harvest kidneys from live donors for transplantation, but any clinical effect of this is uncertain.

3   Further information

3.1  This guidance requires that clinicians undertaking the procedure make special arrangements for audit. NICE 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.

3.2  For related NICE guidance see www.nice.org.uk

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee

May 2011

_{Personal data will not be posted on the NICE website. In accordance with the Data Protection Act names will be anonymised, other than in circumstances where explicit permission has been given.}

 _{It is the responsibility of consultees to accurately cite academic work in order that they can be validated.}