Interventional procedure consultation document

Incisionless otoplasty

Incisionless surgery to correct protruding ears

Protruding ears can be distressing to the person who has them. This procedure aims to improve the appearance of the ear without cutting into the skin. A hollow needle is used to divide the ear cartilage, and stitches buried under the skin are used to remould the ear.

The National Institute for Health and Clinical Excellence (NICE) is examining incisionless otoplasty and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. NICE’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 incisionless otoplasty.

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 provisional recommendations
• the identification of factual inaccuracies
• additional relevant evidence, with bibliographic references where possible.

Note that this document is not NICE’s formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that NICE 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• The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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 NICE website (www.nice.org.uk/ipprogrammemanual).

Through its guidance NICE is committed to promoting race and disability equality, 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 interventional procedures guidance. In particular, we aim to encourage people and organisations from groups who might not normally comment on our guidance to do so.

In order to help us promote equality through our guidance, we should be grateful if you would consider the following question:

Are there any issues that require special attention in light of NICE’s duties to have due regard to the need to eliminate unlawful discrimination and promote equality and foster good relations between people with a characteristic protected by the equalities legislation and others?

Please note that NICE reserves the right to summarise and edit comments received during consultations or not to publish them at all where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate.

Closing date for comments: 19 August 2011

Target date for publication of guidance: November 2011

1   Provisional recommendations

1.1   Incisionless otoplasty comprises a variety of surgical techniques carried out via minimal percutaneous access, that have been poorly described in the evidence, which includes a very small number of patients. The evidence on efficacy and safety is inadequate both in quality and quantity, and therefore the procedure should only be used with special arrangements for clinical governance, consent and audit or research.

1.2   Clinicians wishing to undertake incisionless otoplasty should take the following actions.

• Inform the clinical governance leads in their Trusts.
• Ensure that patients and/or their parents or carers 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 (available from www.nice.org.uk/IPGXXXpublicinfo). [[details to be completed at publication]]
• Audit and review clinical outcomes of all patients having incisionless otoplasty(see section 3.1).

1.3   Further research on incisionless otoplasty should describe the precise surgical techniques used and should document both short and long-term outcomes, including the need for further procedures.

2   The procedure

2.1   Indications and current treatments

2.1.1   Protruding or prominent ears result from a failure to form normal cartilaginous folds within the ear.

2.1.2   Surgery to correct protruding ears aims to reposition the elastic cartilage permanently while preserving a natural appearance. Cartilage-sparing techniques avoid excision and use measures such as scoring, drilling and suturing to reduce the cartilage spring. Standard techniques usually involve a post-auricular incision.

2.2   Outline of the procedure

2.2.1   Incisionless otoplasty avoids the use of a standard incision, which can sometimes be complicated by anterior skin necrosis or a keloid scar formation.

2.2.2   The procedure is usually carried out with the patient under general anaesthesia, but it can also be done under local anaesthesia. Precise details of the procedure depend on the nature of ear abnormalities, the needs of the individual patient and the preferences of the surgeon. In an optional first stage, a needle is inserted into the anterior aspect of the ear and used to score the anterior surface of the cartilage and render it more malleable. A posterior approach is then used to insert subcutaneous retention sutures (usually non-absorbable) to create a natural looking antihelix with less ear protrusion. Conchal cartilage may also be anchored onto the mastoid bone by a subcutaneous stitch attached to non-elastic tissue such as the periosteum.

Sections 2.3 and 2.4 describe efficacy and safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview, available at www.nice.org.uk/guidance/IP/924/overview

2.3   Efficacy

2.3.1   A case series of 13 patients (5 of whom were treated by incisionless otoplasty) reported that photographs showed good correction and that all patients and their families were satisfied with the outcome.

2.3.2   A case series of 11 patients reported that all results were ‘satisfactory’ with no recurrence during 6- to 30-month follow-up.

2.3.3   The case series of 13 patients reported suture breakage or knot unravelling in 1 patient at 1 month. A replacement suture was required (it is unclear whether this patient had been treated by incisionless otoplasty).

2.3.4   The Specialist Advisers listed key efficacy outcomes as aesthetic ear correction and avoidance of recurrence.

2.4   Safety

2.4.1   No safety concerns were reported in the published literature.

2.4.2   The Specialist Advisers listed anecdotal adverse events as bleeding, bruising, anterior skin necrosis, poor aesthetic outcome, and collapse of the ear necessitating reconstruction with costal cartilage.

2.5   Other comments

2.5.1   The Committee noted the psychological distress caused by protruding ears and the potential benefit of effective treatment, in particular by procedures that minimise scarring. However, the limited publications available provided inadequate evidence to suggest that incisionless otoplasty is an efficacious procedure. The Committee expressed particular disappointment at the paucity of the evidence base.

3   Further information

3.1   This guidance requires that clinicians undertaking the procedure make special arrangements for audit. NICE 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.

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee

June 2011

_{Personal data will not be posted on the NICE website. In accordance with the Data Protection Act names will be anonymised, other than in circumstances where explicit permission has been given.}

_{It is the responsibility of consultees to accurately cite academic work in order that they can be validated.}