Secondary Breast Reconstruction With a Flap of Skin From the Back

The purpose of this study is to examine the different outcomes of breast reconstruction in women who are treated for breast cancer with mastectomy and subsequently have delayed breast reconstruction by one of two different surgical techniques both of which are based on the use of a tissue flap from the patient's back. These techniques are either a latissimus dorsi flap (LD-flap) or a thoracodorsal artery perforator flap (TAP-flap) The main objective of the study is to establish whether one of these techniques may result in a superior outcome and thus should be recommended as first choice treatment rather than the other.

Sex

Female

Minimum age

18 Years

To avoid bias relating to the possible effect on the outcome measures caused by other surgical procedures such as mastectomy and axillary surgery performed simultaneously with the reconstruction only delayed procedures will be studied, as these are also most commonly the cases where autologous tissue transfer is required.

Patients that should thus be assessed for eligibility will include all women referred to the participating centres for unilateral, delayed breast reconstruction in the inclusion period. The criteria for participation are as follows:

Inclusion criteria:

1\) Women over 18 years of age who are referred in the period between 1st of September 2013 and 30st of August 2015 for the purpose of unilateral, delayed breast reconstruction, and who are found best suited for reconstruction with a pedicled tissue flap from the back.

Exclusion criteria

1. Patients found better suited for reconstruction by another method i.e. abdominal or free flap-reconstruction or expander/implant-based reconstruction.
2. Patients with severe dementia that makes it impossible to collect data or obtain informed consent
3. Non-Danish speaking patients from whom informed consent cannot be obtained by interpreter
4. Patients where a suited perforator of the Thoracodorsal artery cannot be identified by colour Doppler ultrasonography.

All women referred for delayed breast reconstruction in the inclusion period will be assessed for eligibility and those meeting the criteria of the study population will be invited to participate in the study. The assessment will be conducted at the preliminary examination in the outpatient clinic by one of the centres consultants assigned to the trial.

Invited patients will receive both oral and written participant information after which a period of minimum 14 days is required before the patient can be enrolled in the trial in accordance with the The Danish Health Act.

Patients considering participation will be invited for a second consultation where written informed consent will be obtained from all who accept the invitation. Randomization will be performed immediately afterwards allocating the patient to reconstruction by either the LD-flap or the TAP-flap. Patients who do not which to be enrolled in the trial will be offered reconstruction with the LD-flap as this must be considered standard of care.

• BACKGROUNDBonomi S, Settembrini F, Salval A, Gregorelli C, Musumarra G, Rapisarda V. Current indications for and comparative analysis of three different types of latissimus dorsi flaps. Aesthet Surg J. 2012 Mar;32(3):294-302. doi: 10.1177/1090820X12437783. PMID 22395320
• BACKGROUNDPerdikis G, Koonce S, Collis G, Eck D. Latissimus dorsi myocutaneous flap for breast reconstruction: bad rap or good flap? Eplasty. 2011;11:e39. Epub 2011 Oct 17. PMID 22031843
• BACKGROUNDGarusi C, Lohsiriwat V, Brenelli F, Galimberti VE, De Lorenzi F, Rietjens M, Rossetto F, Petit JY. The value of latissimus dorsi flap with implant reconstruction for total mastectomy after conservative breast cancer surgery recurrence. Breast. 2011 Apr;20(2):141-4. doi: 10.1016/j.breast.2010.10.007. Epub 2010 Nov 11. PMID 21074437
• BACKGROUNDHammond DC. Latissimus dorsi flap breast reconstruction. Plast Reconstr Surg. 2009 Oct;124(4):1055-1063. doi: 10.1097/PRS.0b013e3181b6bf05. PMID 19935289
• BACKGROUNDDejode M, Bordes V, Jaffre I, Classe JM, Dravet F. [Oncologic, functional, and aesthetics results; evaluation of the quality of life after latissimus dorsi flap breast reconstruction. About a retrospective series of 450 patients]. Ann Chir Plast Esthet. 2011 Jun;56(3):207-15. doi: 10.1016/j.anplas.2011.01.003. Epub 2011 Mar 29. French. PMID 21450385
• BACKGROUNDForthomme B, Heymans O, Jacquemin D, Klinkenberg S, Hoffmann S, Grandjean FX, Crielaard JM, Croisier JL. Shoulder function after latissimus dorsi transfer in breast reconstruction. Clin Physiol Funct Imaging. 2010 Nov;30(6):406-12. doi: 10.1111/j.1475-097X.2010.00956.x. PMID 20633032
• BACKGROUNDFaucher A, Barrault M, Duguey I. [Contribution to the study of painful and functional sequellae after breast reconstruction using latissimus dorsi flap. Investigation into 149 patients]. Ann Chir Plast Esthet. 2010 Apr;55(2):104-10. doi: 10.1016/j.anplas.2009.04.008. Epub 2009 Oct 29. French.