Laparoscopic mobilisation of the greater omentum for breast reconstruction (interventional procedures consultation)

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

Interventional Procedure Consultation Document

Laparoscopic mobilisation of the greater omentum for breast reconstruction

The aim of breast reconstruction is to restore the shape, size and texture of the breast after surgery, usually following cancer. The greater omentum is a sheet of fat tissue that is attached to the stomach, and can be used to reconstruct the breast. In this procedure, the greater omentum is released from its surrounding tissue and drawn to the breast through the chest wall, using a number of small incisions ('keyhole' surgery).

The National Institute for Health and Clinical Excellence is examining laparoscopic mobilisation of the greater omentum for breast reconstruction 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 laparoscopic mobilisation of the greater omentum for breast reconstruction.

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The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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/ipprogrammemanual).

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: 20 November 2007
Target date for publication of guidance: February 2008

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

1	Provisional recommendations

1.1	Current evidence on the safety and efficacy of laparoscopic mobilisation of the greater omentum for breast reconstruction is based on limited numbers of patients. However, it is a variation of the open technique, the safety and efficacy of which are known. Therefore, the evidence is considered adequate to support the use of this procedure provided that normal arrangements are in place for consent, audit and clinical governance.
1.2	During consent, patients should be informed that the volume of omentum may be insufficient for full reconstruction and that further, more complex procedures may be required.
1.3	Patient selection should be carried out in the context of a multidisciplinary team experienced in the management of patients requiring breast reconstruction, and should include a breast cancer specialist and a surgeon experienced in laparoscopic techniques.

The procedure

2.1

Indications

2.1.1

Breast reconstruction is commonly carried out in the context of breast cancer treatment, either at the time of breast cancer surgery or at a later date. The aim of breast reconstruction is to create a new breast that is similar in size, shape and texture to the one that was removed.

2.1.2

Breast reconstruction may involve the use of either prosthetic material (breast implant) or autologous tissue (usually from the patient's abdomen, buttocks or back), or a combination of the two. In prosthetic reconstruction, an implant is inserted under the skin or muscle.

2.1.3

In autologous tissue reconstruction, either a free or a 'pedicled' (or 'mobilised') flap can be used. Free flap reconstruction usually involves removing skin, fat and sometimes muscle from the lower abdomen or buttock, and grafting it to the breast area, using microsurgery to establish a new blood supply. Pedicled flap reconstruction usually involves channelling of skin, muscle and fat from the back or abdomen through to the chest, with the tissue flap remaining connected to its original blood supply. If there is not enough tissue to create a whole breast, an implant may also be used. Although pedicled and free flaps are conventionally harvested by open surgery, endoscopic techniques have recently been developed with the aims of minimising the scars caused by skin incisions and speeding recovery.

2.2

Outline of the procedure

2.2.1

Breast reconstruction with a laparoscopically harvested omental flap is usually carried out at the same time as breast surgery. Under general anaesthesia, the greater omentum is detached from the colon and stomach laparoscopically. This procedure can be performed for either a pedicled or a free flap.

2.2.2

When a pedicled flap is used, the greater omentum remains connected to the terminal branch of the right gastroepiploic artery. A skin-sparing mastectomy is performed, with axillary lymph node clearance as required, and a subcutaneous tunnel is created from the inframammary skinfold. Forceps are then inserted into the abdominal cavity through an incision at the linea alba to draw the greater omentum through the tunnel and into the mastectomy wound.

2.2.3

When a free flap is used, the origins of the right gastroepiploic vein and artery are clipped and resected. The flap is removed through a small incision in the lower abdominal wall and inserted in the mastectomy wound. Microsurgery is used to connect the gastroepiploic artery to the internal mammary artery.

2.2.4

With both pedicled and free flaps, the omental tissue is fixed to the pectoralis major muscle with staples or sutures, and the mastectomy incision is closed. A gravity drain is placed in the area of the reconstruction.

2.3

Efficacy

2.3.1

In a case series of 44 women, cosmetic results were reported to be 'mostly satisfactory'; the reconstructed breast being soft in texture and natural in appearance. No size reduction of the reconstructed breast was noted during follow-up (median 25 months). In a case series of 10 women, the results were reported to be 'very satisfactory' in 6 patients (evaluated by two plastic surgeons comparing pre-operative and postoperative photographs); none of the patients reported dissatisfaction with the cosmetic result.

2.3.2

In the two case series, omental flaps of inadequate volume were reported in 11% (5/44), and 20% (2/10) of women. They were therefore combined with lattisimus dorsi myoflaps (in the first series) or implant insertion (in the second series). For more details, refer to the sources of evidence (see appendix).

2.3.3

All the Specialist Advisers noted that it would be difficult to determine in advance how much of the omentum could be harvested and whether it would be adequate for breast reconstruction.

2.4

Safety

2.4.1

The case series of 44 women reported that 4 (9%) developed wound or graft infections, which were treated conservatively; 1 woman (2%) suffered a 'minor' vascular injury and 1 (2%) developed an epigastric hernia. None of the women was reported to have suffered local or systemic breast cancer recurrence after a median follow-up of 25 months.

2.4.2

In the case series of 10 women, 1 reported epigastric pain, which persisted for 4 months (resolved with medication), and 1 developed partial necrosis of an areolar graft implanted during the same operation. There were no reports of women developing abdominal wall hernias or local or systemic recurrence of breast cancer by the end of follow-up (period not stated). For more details, refer to the sources of evidence (see appendix).

2.4.3

The Specialist Advisers listed the possible adverse events as including partial flap necrosis, vascular injury, wound and graft infection, epigastric hernia and inadequate flap volume. They considered the additional theoretical events (compared with open surgery) to include the risk of seeding tumour cells into the peritoneal cavity, vascular damage leading to total flap loss, damage to intra-abdominal organs during harvest, referred pain (through autonomic nervous system), and impact on future abdominal surgery (lack of greater omentum to defend against intra-abdominal sepsis).

Further information

3.1

The Institute has developed clinical guidelines on familial breast cancer (classification and care of women at risk in primary, secondary and tertiary care) (www.nice.org.uk/guidance/CG41) and is developing clinical guidelines on the diagnosis and treatment of both early and advanced breast cancer (www.nice.org.uk/page.aspx?o=guidelines.inprogress.breastcancer9 and www.nice.org.uk/page.aspx?o=395068).

Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
October 2007

Appendix:

Sources of evidence

The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.

'Interventional procedure overview of laparoscopic mobilisation of the greater omentum for breast reconstruction', July 2007.

Available from: www.nice.org.uk/ip414overview.

This page was last updated: 30 March 2010