Short summary

The purpose of this study is to examine 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 pedicled tissue flap from the patient's back.

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.

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Rationale

Women, who are treated for breast cancer with mastectomy, are usually eligible for subsequent reconstruction of the breast. Depending on various conditions the reconstruction can be either immediate or delayed.

Several different surgical techniques for delayed breast reconstruction have been described. An important factor that applies to delayed reconstruction is the lack of excessive, healthy skin in the area where the breast has been removed and the purpose of the surgical techniques developed for this are therefore to provide sufficient amounts of skin and/or other tissues to recreate the contour of the breast. The methods for this can broadly be classified as either expander/implant based or autologous-tissue based. Though full autologous reconstruction is preferred by many surgeons and patients due to the superior result, this is not always possible, which is why an implant can be needed in combination with the tissue flap to provide sufficient volume.

In the irradiated patient simple expansion of the skin is often impossible and transfer of autologous tissue is normally required. A wide armamentarium of different methods is available utilizing either pedicled or free flaps for tissue transfer. The most widely used techniques for this in general are reconstruction with abdominal flaps. However, when these women are not eligible for either reconstruction with an abdominal flap or microsurgical reconstruction with other free flaps a well-known and much used technique for reconstruction is the Latissimus Dorsi-flap (LD-flap).

At Lillebaelt Hospital in Vejle, Denmark, we have adopted a new technique for total breast reconstruction as an alternative to the LD-flap in July 2011. This method makes use of a fasciocutaneous flap, which is also raised from the patient's back. Tough the blood supply also derives from the Thoracodorsal artery imbedded in the Latissimus Dorsi muscle the flap only contains skin and subcutaneous tissue. The perfusion of blood is instead supplied through a perforator artery, normally arising from the descending branch of the main vessel. This flap is called a Thoracodorsal Artery Perforator-flap (TAP-flap/TDAP-flap) and was first described in the literature in 1995.

We have chosen to perform a modified version of the technique combining the TAP-flap and implant with the use of an acellular dermal matrix (ADM). This matrix is used to drape the lower pole of the implant and in a sense creates an internal bra that supports the prosthesis. We presume that this in part replaces the supportive effect that is normally provided by the muscle when using the LD-flap. The ADM is thus used as a substitute for the patient's own tissue and will over time become integrated as a part of it.    

Though the TAP flap is well-described for several reconstructive purposes, application of the flap as a tool for total breast reconstruction is a new endeavour and its importance has not yet been established. Based on the flaps properties and the more gentle dissection/harvest of the tissue, which leaves the underlying Latissimus Dorsi muscle intact we presume the application of this new technique to facilitate a statistically significant reduction in the associated morbidity in terms of impairment and/or chronic pain in the shoulder, back and upper arm which can been experienced after LD-flap based reconstruction. Furthermore we expect the use of the TAP-flap to cause a decrease in the need for postoperative physical rehabilitation in terms of physiotherapy and training. The aim of this study is thus to test whether this hypothesis is true in order to establish whether the TAP-flap based reconstruction offers any advantages should be favoured above the conventional LD-based reconstruction.

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Description of the cohort

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:

• 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

• Patients found better suited for reconstruction by another method i.e. abdominal or free flap-reconstruction or expander/implant-based reconstruction.
• Patients with severe dementia that makes it impossible to collect data or obtain informed consent
• Non-Danish speaking patients from whom informed consent cannot be obtained by interpreter
• 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 center's consultants assigned to the trial.

Data and biological material

Primary Outcome Measure

• Shoulder Function: The most important difference between the two procedures is the involvement of the muscle and change in shoulder function is the most relevant clinical measure to investigate. For evaluation of shoulder function we use the internationally validated Constant Shoulder Score (CSS). This score assess pain, function in everyday-life, range of motion and strength and incorporates these parameters into one total score.

Secondary Outcome Measures

• Patient Reported Discomfort: As the pain-related outcome measure in the CSS only concerns pain in the shoulder an assessment of the patients experience of pain and/or tightening in the neck, back, arm or breast will be performed at baseline and 3, 6 and 12 months postoperatively.
• Rehabilitation: The patients need for physical rehabilitation and training will be addressed as the second most important supportive secondary end-point. A patient reported quantification of the time spent weekly on either physiotherapy or training targeted on the shoulder, arm and/or back will be made at baseline. All patients will follow the same rehabilitation program in the postoperative phase and for the first 3 months after surgery. Hereafter the rehabilitation will be individual and based on their specific needs.

Other Outcome Measures

• Quality-of-life: The patients' quality-of-life will be assessed before and after reconstruction using the international validated questionnaire developed The European Organization for Research and Treatment of Cancer (EORTC) for assessment of life quality in cancer patients. Patients will be asked to complete the general questionnaire QLQ-30 in combination with the additional questionnaire QLQ-BR23 that has been specifically developed for cancer patients with breast-related diseases. The questionnaires will be completed in the outpatient clinic preoperatively and again 12 months after surgery.
• Socio-economics: In order to evaluate the socio-economic aspects and cost-benefit associated with the use of each surgical technique we record the following parameters for all patients: Duration of operation, duration of hospitalization, duration of entire course of the breast reconstruction, duration of sick leave and need for revisional/correctional procedures.
• Aesthetic Outcome: We wish to conduct an evaluation of the aesthetic result of the different reconstructions including a professional assessment and an assessment from the patient. Hence all patients will be asked to evaluate the appearance of their bosom on a scale from 1 to 10 indicating their satisfaction with the reconstruction. Furthermore the patients will be subjected to a professional evaluation as all women will have their bosom photographed. Photographs will be evaluated by two unbiased medical consultants specializing in plastic surgery who are not associated with the department or the project. These specialists will be asked to perform the same evaluation as the patients. Both the patient's and the specialist's evaluation will be performed before surgery and once again at the final consultation in the outpatient clinic 12 months following the reconstruction.
• Complications: Complications following the surgery will be recorded continuously during hospitalization and in the outpatient's clinic. They will include: skin necrosis and/or delayed healing, infection, seromas, bleeding, flap-necrosis and explanation. Complications will be classified as either major or minor depending on the need for surgical revision.

There will be no collection of biological material.

Collaborating researchers and departments

Department of Plastic Surgery, Odense University Hospital

• Jørn Bo Thomsen, MD, PhD
• Ann Udesen, MD

Department of Plastic Surgery, Telemark Hospital, Skien, Norway

• Gudjon Gunnarsson, MD

Department of Plastic Surgery, Herlev Hospital

• Tina Tos, MD, Lisbet Hölmich

Publications associated with the project

Direct Delayed Breast Reconstruction with TAP-flap, Implant and Acellular Dermal Matrix (TAPIA). / Børsen-Koch M, Gunnarsson GL, Udesen A, et al. J Plast Reconstruct Aestheth Surg. (Epub ahead of print)