Laparoscopic prostatectomy for benign prostatic obstruction (interventional procedures consultation)

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

Interventional Procedure Consultation Document

Laparoscopic prostatectomy for benign prostatic obstruction

The prostate gland surrounds the outlet of a man's bladder. Benign prostatic obstruction occurs when the prostate gland gets bigger, squeezing the tube that carries urine from the bladder to the tip of the penis (the urethra). It can cause problems with passing urine. Laparoscopic prostatectomy involves removing the prostate gland through small cuts in the abdomen, using a fine telescope to see inside the body (also known as ‘keyhole surgery').


The National Institute for Health and Clinical Excellence is examining laparoscopic prostatectomy for benign prostatic obstruction 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 prostatectomy for benign prostatic obstruction.

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  • The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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

NICE is committed to promoting through its guidance race and disability equality and 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 guidance on interventional procedures. In particular, we aim to encourage people and organisations from groups in the population who might not normally comment on our guidance to do so. We also ask consultees to highlight any ways in which draft guidance fails to promote equality or tackle discrimination and how it might be improved.

Closing date for comments: 26 August 2008
Target date for publication of guidance: November 2008


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 Current evidence on the safety and efficacy of laparoscopic prostatectomy for benign prostatic obstruction (BPO) is inadequate in both quantity and quality. Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit or research.
1.2

Clinicians wishing to undertake laparoscopic prostatectomy for BPO associated 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 make them aware of alternative treatment options. 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]]
1.3 This procedure should only be carried out by surgeons with special training and experience in laparoscopic radical prostatectomy.
1.4 Patients should only be offered this procedure if they would otherwise be considered for open prostatectomy, rather than transurethral resection, for BPO.
1.5 Clinicians should submit data on all patients who receive this procedure to the British Association of Urological Surgeons Cancer Registry & Sections Audit (www.baus.org.uk/baus_subspecialty_sections/baus_cancer_registry__sections_audit.phtml).
1.6 NICE may review the procedure on publication of further evidence.
   
2 The procedure
2.1 Indications and current treatments
2.1.1 BPO occurs when the prostate enlarges, pressing against the urethra and the outlet from the bladder. Symptoms include a poor urine stream, urinary frequency, urgency, leaking or dribbling, and urinary retention.
2.1.2 Mild symptoms can be treated by medical therapy to relax the smooth muscles of the prostate and bladder neck, reduce prostate size or prevent further enlargement. When medical therapy is inadequate, patients may be treated surgically, usually by transurethral prostatectomy. If the prostate is very large, then open prostatectomy (Millin's operation) or transurethral holmium laser prostatectomy may be considered; laparoscopic prostatectomy is a possible alternative for these patients.    
2.2 Outline of the procedure
2.2.1 Laparoscopic prostatectomy is performed with the patient under general anaesthesia, using either a trans- or an extra-peritoneal approach, with or without computer assistance. Incisions are made in the lower abdomen to provide access for the laparoscope and surgical instruments. A transverse incision is made on the anterior wall of the prostate capsule. The glandular tissue of the prostate is freed from the prostate capsule and removed through the umbilical port incision. A catheter is inserted and the prostate capsule is closed with sutures. If a transvesical approach is used, an incision is made in the bladder neck to expose the prostate.
Sections 2.3 and 2.4 describe efficacy and safety outcomes which were available in the published literature and which the Committee considered as part of the evidence about this procedure.  For more details, refer to the Sources of evidence.    
2.3 Efficacy
2.3.1 A non-randomised comparative study of 20 patients treated by laparoscopic prostatectomy and 20 patients treated by open surgery reported similar mean postoperative International Prostate Symptom Score (IPSS) scores in the two groups, of 10 and 6.7, respectively (p = 0.5) (pre-operative scores 20.9 and 17.8, respectively; p = 0.3) (IPSS scores, 0–35 scale from mild to severe symptoms).
2.3.2 The same study of 20 patients reported no significant difference between the mean postoperative maximum flow rates of 27.2 and 25.4 ml/s in the laparoscopic and open surgery groups, respectively (p = 0.5) (8.8 and 7.7 ml/s pre-operatively; p = 0.4).
2.3.3 Four case series of 100, 60, 17 and 7 patients reported mean postoperative IPSS scores of 3.0, 5.2, 9.9 and 7.2 (24.2, 28.3, 24.5 and 22 pre-operatively).    
2.3.4 Two case series of 100 and 60 patients reported mean postoperative maximum flow rates of 26.4 and 19.9 ml/s, respectively (6.0 and 4.8 ml/s pre-operatively).    
2.3.5 The Specialist Advisers considered key efficacy outcomes to include reduced blood loss, shorter hospital stay, improved postoperative flow rate and relief of urinary symptoms.    
2.4 Safety
2.4.1 The Specialist Advisers considered key efficacy outcomes to include reduced blood loss, shorter hospital stay, improved postoperative flow rate and relief of urinary symptoms.
2.4.2 The non-randomised comparative study of 60 patients and two case series of 17 and 7 patients reported that blood transfusions were required in 3% (1/30), 29% (5/17) and 14% (1/7) of patients. The non-randomised comparative study of 40 patients reported bleeding requiring re-operation in 5% (1/20) of patients. The case series of 17 patients reported haemorrhage (not otherwise specified) in 6% (1/17) of patients.
2.4.3 Two case series of 100 and 60 patients reported urinary infection in 2% (2/100) and 5% (3/60) of patients, respectively; there was 1 case of septicaemia. The non-randomised comparative study of 60 patients reported port-site infection in 3% (1/30) of patients.    
2.4.4 Three case series of 60, 18, and 17 patients each reported 1 patient with clot retention. The comparative study of 40 patients and case series of 18 patients reported urethral stricture in 5% (1/20) and 6% (1/18) of patients. The non‑randomised comparative study of 60 patients reported bladder stenosis in 3% (1/30) of patients. The case series of 60 patients reported retrograde ejaculation in 68% (41/60) of patients at 6-month follow-up.    
2.4.5 The Specialist Advisers considered theoretical adverse events to include bleeding, rectal injury, bladder neck stenosis, incontinence, leakage of urine from the bladder and damage to ureteric orifices.    
3 Further information    
3.1 NICE has published interventional procedures guidance on laparoscopic radical prostatectomy (www.nice.org.uk/IPG193) and holmium laser prostatectomy (www.nice.org.uk/IPG17).    

Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
July 2008

Appendix: Sources of evidence
 
The evidence considered by the Interventional Procedures Advisory Committee is described in the overview, available at: www.nice.org.uk/ip36overview.

This page was last updated: 30 March 2010