The Interventional Procedures Advisory Committee (IPAC) reconsidered this procedure in light of the HTA Programme-funded evaluation of the National Specialist Commissioning Advisory Group (NSCAG) service. The National Institute for Health and Clinical Excellence (NICE) has issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on stimulated graciloplasty for faecal incontinence.
This procedure is used to treat otherwise intractable faecal incontinence.
Stimulated graciloplasty involves the creation of a new anal sphincter using transposed gracilis muscle. The muscle is moved from the thigh and implanted with electrode from an electric pulse generator. The continuous current of the pulse generator gradually converts the skeletal muscle fibres of the gracilis into smooth muscles fibres, thus allowing sustained contraction of the new anus and producing continence to faeces.
The procedure can be performed in stages, or all at once. Generally it involves mobilising one or both gracilis muscles by detaching the muscles from the knee ligament. The muscle remains fastened to its pelvic attachments with the blood supply intact, but is brought up into the abdomen, where it is placed around the anus, which may be pre-existing but not functioning, or be created from other tissues such as colon pulled through after an operation such as abdominoperineal resection. The 'knee-end' of the gracilis is fastened to the contralateral pelvis. A pulse generator is implanted in the abdomen and electrodes are implanted in the gracilis.
Training of the gracilis begins some weeks after the operation, with the periods that the pulse generator is switched on gradually increasing until the conversion of the gracilis fibres from skeletal to smooth muscle is largely completed.
The standard intervention for otherwise intractable faecal incontinence is colostomy.
This guidance represents the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take this guidance fully into account, and specifically any special arrangements relating to the introduction of new interventional procedures. The guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
All problems (adverse events) related to a medicine or medical device used for treatment or in a procedure should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card Scheme.
Commissioners and/or providers have a responsibility to implement the guidance, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties. Providers should ensure that governance structures are in place to review, authorise and monitor the introduction of new devices and procedures.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.