Interventional Procedure Consultation Document - Stimulated graciloplasty for faecal incontinence (second consultation)

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

Interventional Procedure Consultation Document

Stimulated graciloplasty for faecal incontinence

The National Institute for Health and Clinical Excellence is examining stimulated graciloplasty for faecal incontinence and will publish guidance on its safety and efficacy to the NHS in England, Wales and Scotland. 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 stimulated graciloplasty for faecal incontinence.
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  • The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales and Scotland.

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: 20 December 2005
Target date for publication of guidance: March 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

Current evidence on the safety and efficacy of stimulated graciloplasty for faecal incontinence is limited, but appears sufficient to support the use of this procedure for carefully selected patients in whom other treatments have failed, provided that the normal arrangements are in place for consent, audit and clinical governance

1.2

This procedure should be performed only in specialist units by clinicians with specific training and experience in the assessment and treatment of faecal incontinence.



2 The procedure
2.1 Indications
2.1.1

Stimulated graciloplasty is used to treat refractory faecal incontinence, as an alternative to colostomy. Other approaches aimed at establishing continence are insertion of an artificial anal sphincter and sacral nerve stimulation.

2.2 Outline of the procedure
2.2.1 Stimulated graciloplasty involves creating a new anal sphincter using transposed gracilis muscle. Electrodes are implanted in the transposed muscle and connected to an electric pulse generator implanted in the abdominal wall. A continuous current from the pulse generator gradually alters the character of the gracilis muscle fibres.
2.2.2

The procedure can be performed in one or two stages. In the latter case, the muscle wrapping precedes the electrode implantation stage by a few weeks.

 
2.3 Efficacy
2.3.1

A systematic review of 37 studies of graciloplasty found that between 42% and 85% of patients became continent after the procedure (different definitions of continence were used and continence was assessed at different time points in the studies). A controlled study found that at 24 months, frequency of incontinence had significantly improved from baseline in 48 patients who had undergone graciloplasty (p < 0.0001); there was no improvement during this period in patients who were not offered surgery. A case series reported successful outcomes in 72% (144/200) of patients, with 5-year follow-up.

2.3.2 A controlled trial found that quality of life improved more in patients treated with graciloplasty (n = 46) than in those not offered surgery who were being medically managed (n = 40). The following scales were used to assess quality of life: the Cleveland Clinic Faecal Incontinence Scale (p = 0.001); the Hospital Anxiety and Depression Scale for anxiety (p = 0.03) and depression (p = 0.05); and a validated study-specific scale for psychological wellbeing (p < 0.0001) and lifestyle characteristics (p < 0.0001). In a case series of 129 patients who had graciloplasty, patients' quality of life was significantly improved on the SF 36 scale for physical and social functioning at 12 months' follow-up. For more details, refer to the sources of evidence (see Appendix).
2.3.3

The Specialist Advisors suggested that this procedure has been largely superseded by sacral nerve stimulation.

 

2.4 Safety
2.4.1

The most common complication of stimulated graciloplasty is wound infection. In a systematic review that included 403 patients assessed for safety outcomes, the overall rate of infection was 28%. In a case series of 121 patients, serious infection needing hospitalisation and/or surgery was reported in 15% of patients, and in another series it occurred in 14% (17/123) of patients.

2.4.2 Electrical or technical problems with the pulse generator leading to hospitalisation occurred in 48% (23/48) of patients who had undergone graciloplasty in a controlled trial at 42 months' follow-up. In a case series of 123 patients, 3 patients (2%) had a deep vein thrombosis and one patient died following a pulmonary embolism 3 weeks after surgery.
2.4.3 In a comparative study 69% (33/48) patients had evacuation difficulties or pain requiring hospitalisation following graciloplasty. Disturbed evacuation was reported in 16% (32/200) of patients in a prospective case series. For more details, refer to the sources of evidence (see Appendix).
2.4.4 The Specialist Advisors noted that the main reported adverse events were related to the pulse generator, particularly the risk of infection (both in the short and the long term).


3 Further information
3.1

The Institute has produced guidance on sacral nerve stimulation for faecal incontinence (www.nice.org.uk/IPG099).

Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
December 2005

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 procedure overview of stimulated graciloplasty, June 2005

Available from: www.nice.org.uk/IP019overview

This page was last updated: 04 February 2011