Transabdominal artificial bowel sphincter implantation for faecal incontinence

# Guidance
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.
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 NICE's information for patients ('Understanding NICE guidance') is recommended.
Audit and review clinical outcomes of all patients having transabdominal artificial bowel sphincter implantation for faecal incontinence (see section 3.1).# The procedure

# Indications and current treatments
Faecal incontinence is caused by a variety of conditions that can affect either the anatomy or function of the anal sphincter. These conditions include perineal injury during childbirth, 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, or pelvic radiotherapy.
First-line treatment for faecal incontinence is usually conservative and includes dietary management and antidiarrhoeal medication. 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. If local surgery proves inadequate, alternatives 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.

# Outline of the procedure
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 with the patient 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.
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 the 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 detailed information on the evidence, see the overview.

# Efficacy
A case series of 12 patients reported that 75% (9/12) of patients had a functioning implant at a median follow-up of 59 months (range 3072 months). Five of the 9 (56%) required surgical revision (4 to replace the pump and 1 because of strap disruption). In the same study, the median Cleveland Clinic Incontinence Score (in which the maximal faecal incontinence score is 20) improved from 16 (range 720) before the procedure to 3 (range 07) after the procedure in the 10 patients whose faecal incontinence could be assessed.
The Specialist Advisers stated that key efficacy outcomes include restoration of faecal continence, absence of mucus leakage and improved quality of life.

# Safety
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.
The Specialist Advisers stated that theoretical adverse events include infection, migration of the device within the pelvis, disturbance of the 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.

# Other comments
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.# Further information
This guidance requires that clinicians undertaking the procedure make special arrangements for audit. NICE has identified relevant audit criteria and developed audit support (which is for use at local discretion).
NICE has published a clinical guideline on faecal incontinence and interventional procedures guidance on stimulated graciloplasty, injectable bulking agents, sacral nerve stimulation and artificial anal sphincter implantation (perineal approach), all for faecal incontinence.

# Information for patients
NICE has produced information on this procedure for patients and carers ('Understanding NICE guidance'). It explains the nature of the procedure and the guidance issued by NICE, and has been written with patient consent in mind.# About this guidance
NICE interventional procedure guidance makes recommendations on the safety and efficacy of the procedure. It does not cover whether or not the NHS should fund a procedure. Funding decisions are taken by local NHS bodies after considering the clinical effectiveness of the procedure and whether it represents value for money for the NHS. It is for healthcare professionals and people using the NHS in England, Wales, Scotland and Northern Ireland, and is endorsed by Healthcare Improvement Scotland for implementation by NHSScotland.
This guidance was developed using the NICE interventional procedure guidance process.
We have produced a summary of this guidance for patients and carers. Tools to help you put the guidance into practice and information about the evidence it is based on are also available.
Changes since publication
January 2012: minor maintenance.
Your responsibility
This guidance represents the views of NICE and was arrived at after careful consideration of the available evidence. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. This guidance does not, however, override the individual responsibility of healthcare professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
Implementation of this guidance is the responsibility of local commissioners and/or providers. Commissioners and providers are reminded that it is their responsibility to implement the guidance, in their local context, in light of their duties to avoid unlawful discrimination and to have regard to promoting equality of opportunity. Nothing in this guidance should be interpreted in a way which would be inconsistent with compliance with those duties.
Copyright
 National Institute for Health and Clinical Excellence 2008. All rights reserved. NICE copyright material can be downloaded for private research and study, and may be reproduced for educational and not-for-profit purposes. No reproduction by or for commercial organisations, or for commercial purposes, is allowed without the written permission of NICE.
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