Transabdominal artificial bowel sphincter implantation for faecal incontinence (interventional procedures consultation)

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NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

Interventional Procedure Consultation Document

Transabdominal artificial bowel sphincter implantation for faecal incontinence

Faecal incontinence occurs when a person loses the ability to control their bowel movements, resulting in leakage of faeces. It can happen as a result of congenital abnormalities of the anal sphincter (the ring of muscle that keeps the anus closed), injury to the sphincter during childbirth or surgery, disease of the nervous system, prolapse of the pelvic organs or pelvic radiotherapy. In this procedure, an inflatable circular cuff is placed in the anorectal area. The cuff is controlled using a pump that is implanted under the skin in the lower half of the abdomen and connected to a reservoir of fluid. Pressure on the pump allows fluid to move to and from the cuff, to open or close the anus and allow bowel movements to be controlled.

The National Institute for Health and Clinical Excellence is examining transabdominal artificial bowel sphincter implantation for faecal incontinence 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 transabdominal artificial bowel sphincter implantation 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The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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: 28 July 2008
Target date for publication of guidance: October 2008

Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.

Provisional recommendations

1.1

Current evidence on the safety and efficacy of transabdominal artificial bowel sphincter implantation for faecal incontinence is based on a small number of patients and is inadequate in quantity. Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit or research.

1.2

Clinicians wishing to undertake transabdominal artificial bowel sphincter implantation for faecal incontinence 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 the Institute'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 transabdominal artificial bowel sphincter implantation for faecal incontinence (see section 3.1).


2	The procedure
*2.1*	*Indications* *and current treatments*
2.1.1	The causes of faecal incontinence are diverse and can affect either the anatomy or function of the anal sphincter. They include perineal injury during vaginal delivery, neurological or spinal disease/injury (for example, stroke, multiple sclerosis or spinal cord injury), congenital anorectal dysfunction, pelvic organ prolapse, colonic resection or anal surgery and pelvic radiotherapy. People with severe cognitive impairment are also at risk.
2.1.2	First-line treatment for faecal incontinence involves antidiarrhoeal medication and dietary management. This may be followed by pelvic floor muscle training, biofeedback therapy and electrical stimulation. If conservative treatments fail, local surgery to repair the sphincter may be recommended. Other options for patients in whom local surgery fails include sacral nerve stimulation, graciloplasty (creation of a new sphincter from other suitable muscles) or implantation of an artificial anal sphincter (anorectal or transabdominal). The most severe cases may require a permanent colostomy.

*2.2*	*Outline of the procedure*
2.2.1	Artificial bowel sphincters are usually implanted into the perineum. However, complications (such as infections and erosion of the implant into surrounding tissue) are common at this site, often resulting in surgical revision or removal of the device. Transabdominal implantation aims to achieve a lower rate of complications. Usually under general anaesthesia, a lower mid-line incision is made to allow the inflatable sphincter cuff (consisting of an expander and a gel-filled pillow) to be placed at the anorectal junction and held in place by a strap. A subcutaneous pouch is then created for the control pump, usually in the right iliac fossa. A balloon reservoir is placed within the peritoneal cavity in the pelvis. The connecting tubes from the sphincter cuff and the balloon reservoir are connected to the control pump and the abdomen is closed.
2.2.2	When inflated, the cuff keeps the anal canal closed. To evacuate the bowel, the patient presses the control pump's button against the abdominal wall. This deflates the cuff and opens the sphincter by pumping fluid from the sphincter cuff into the balloon reservoir. On completion of defaecation, the patient closes the sphincter by pressing the button on the pump again. This opens the pump, allowing fluid to return to the cuff and producing angulation between the rectum and anal canal.

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 case series of 12 patients reported that 75% (9/12) of patients had a functioning implant at median follow-up of 59 months (range 30–72 months). Five of the 9 (56%) required surgical revision (4 to replace the pump and 1 because of strap disruption).
2.3.2	In the same study, median Cleveland Clinic continence scores improved from 16 (range 7–20) before to 3 (range 0–7) after surgery in the 10 patients in whom continence could be assessed.
2.3.3	The Specialist Advisers stated that key efficacy outcomes include restoration of continence, absence of mucous leakage and improved quality of life.

*2.4*	*Safety*
2.4.1	The case series of 12 patients reported that 25% (3/12) of patients required removal of the device because of complications, including infection after revision surgery in 2 patients and pseudomembranous colitis during the perioperative period in the third patient.
2.4.2	The Specialist Advisers stated that theoretical adverse events include infection, migration of the device within the pelvis, disturbance of blood supply to the bowel, and rectal injury caused by pressure from the artificial sphincter. One Adviser stated that surgical revision of this procedure is likely to be more difficult than surgical revision after perineal implantation.

*2.5*	*Other comments*
2.5.1	The Committee noted that the technology was modified during the single small case series that reported on this procedure and that further development and modifications are likely to occur.

3	*Further information*
3.1	This guidance requires that clinicians undertaking the procedure make special arrangements for audit. The Institute 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	The Institute has published a clinical guideline on faecal incontinence (www.nice.org.uk/CG049) and interventional procedures guidance on stimulated graciloplasty (www.nice.org.uk/IPG159), injectable bulking agents (www.nice.org.uk/IPG210), sacral nerve stimulation (www.nice.org.uk/IPG099) and artificial anal sphincter implantation (perineal approach) (www.nice.org.uk/IPG066), all for faecal incontinence.

Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
June 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/ip645overview.

This page was last updated: 30 March 2010