The National Institute for Clinical Excellence is examining stimulated graciloplasty and will publish guidance on its safety and efficacy to the NHS in England and Wales. 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. This document has been prepared for public consultation. It summarises the procedure and sets out the provisional recommendation made by the Advisory Committee. 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 the Final Interventional Procedures Document (FIPD) and submit it to the Institute.
• The FIPD may be used as the basis for the Institute's guidance on the use of the procedure in the NHS in England and Wales.

For further details, see the Interim Guide to the Interventional Procedures Programme, which is available from the Institute's website (www.nice.org.uk/ip).

Closing date for comments: 22 July 2003

Target date for publication of guidance: 24 December 2003

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 stimulated graciloplasty does not appear adequate to support the use of this procedure without special arrangements for consent and for audit or research. Clinicians wishing to undertake stimulated graciloplasty outside evaluation arranged by the National Specialist Advisory Commissioning Group (NSCAG) should inform the clinical governance leads in their Trusts. They should ensure that patients offered it understand the uncertainty about the procedure's safety and efficacy and that appropriate arrangements are in place for audit or research. Publication of safety and efficacy outcomes will be useful in reducing the current uncertainty. NICE is not undertaking further investigation at present.

Stimulated graciloplasty is funded by NSCAG. The Department of Health has stipulated that procedures commissioned by NSCAG should not be commissioned or performed other than as part of the NSCAG service.

The Interventional Procedures Advisory Committee will reconsider this procedure at the request of NSCAG, or if NSCAG funding is withdrawn.

Stimulated graciloplasty is used to treat final stage faecal incontinence, as an alternative to the standard procedure, which is colostomy.

Stimulated graciloplasty involves the creation of a new anal sphincter using transposed gracilis muscles (which are adductor muscles in the thigh). Electrodes are implanted in the transposed gracilis muscles and connected to an implanted electric pulse generator.. The continuous current of the pulse generator gradually converts the skeletal muscle fibres of the gracilis into smooth muscle fibres, so allowing sustained contraction of the new anal sphincter and producing faecal continence.

Stimulated graciloplasty can restore continence, whereas colostomy cannot.

The studies reviewed showed that stimulated graciloplasty produced satisfactory continence outcomes in at least 40%, and up to 85%, of patients. For more details refer to the overview (see below).

All Specialist Advisors commented that this procedure is now established practice. They advised that the procedure should be performed in specialist coloproctology units with multidisciplinary expertise, including counselling, physiology and electronics expertise.

One Specialist Advisor identified a higher success rate for patients with faecal incontinence due to sphincter trauma or deficiency, than for patients with no sphincter or no rectum.

A systematic review published in 2002 reported an operative mortality rate of 4%. Infection was the most common complication (reported in 28% of patients in the studies included in the systematic review). One study reported severe complications in 47% of patients, including infection, deep vein thrombosis and pulmonary embolus. For more details refer to the overview (see below).

Specialist Advisors noted that there was a significant rate of infection after the procedure, and that difficulty with rectal evacuation was a common problem. Chronic leg pain was also identified as a potential side effect.

The following source of evidence was considered by the Interventional Procedures Advisory Committee.

• Interventional Procedure Overview of Stimulated Graciloplasty, February 2003