Breast Reconstruction Clinical Trial
Official title:
Delayed Breast Reconstruction With Skin Flap 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.
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 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 if often impossible and transfer of
autologous tissue is normally required. A wide armamentarium of different methods are
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).
Using this method an island of skin and subcutaneous tissue is provided from the upper part
of the patient's back with blood supply deriving from the two main branches of the
thoracodorsal artery, which are imbedded in the underlying Latissimus Dorsi muscle. A so
called musculocutaneous tissue-flap is raised from the patient's back and tunnelled to the
front of the thorax carrying the entire Latissimus Dorsi muscle and the paddle of overlying
skin. At the front of the chest the muscle is usually used to drape a silicone implant, and
the skin is used to recreate the breast mound. This method is very well-described in the
literature, offers a safe and reliable option for breast reconstruction and is often used for
this purpose.
Donor site sequelae are however debated. A direct consequence of transferring the Latissimus
Dorsi muscle during the procedure is loss of the muscles function in the shoulder and upper
arm which involves extension, adduction and rotation of the shoulder joint. Partial
impairment in the form of reduced strength and/or restricted movement is thus to be expected
as is pain and weakness in the neck, shoulder and upper arm. Other muscles can replace the
lost function of the Latissimus Dorsi, and with sufficient rehabilitation and training
patients are expected to regain normal function over time. Long term sequelae in the form of
chronic pain, discomfort, weakness and/or restricted range of motion have been described but
the evidence on this particular area are ambiguous. There are no systematic reviews of the
evidence in the published literature and most papers comprise case reports and retrospective
cohort studies although a few prospective studies also exist. The different papers indicate
varying rates of long-term morbidity associated with the shoulder and arm but the risk of
some impairment and chronic pain cannot be ignored based on the available evidence.
At Vejle Hospital in 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. Although 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 .
Use of the TAP flap as a pedicled perforator flap have been described in several cases aiding
in the treatment of defects on the trunk, upper extremity, head and neck. In the field of
breast surgery it has primarily been used for oncoplastic procedures, although a few papers
describe the preliminary use of the TAP-flap in combination with an implant for total
reconstruction of a breast. As this technique was only recently adopted none of the published
studies examine the long term results nor the advantages of using the TAP-flap. A single
retrospective study investigates shoulder function after harvest of the flap and finds no
affection of the shoulder joint or the upper arm .
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.
Applying this technique the upper part of the silicone implant is covered by the Major
Pectoral muscle, while the lower part is draped by the ADM. The matrix is sutured to the
free, lower edge of the muscle as well as to the chest wall at the desired level of the new
inframammary fold. This covers and fixates the implant relieving pressure on the flap which
is afterwards used to cover the reconstructed mound. We believe this enhances sufficient
blood supply to the flap and thus provides the most optimal conditions in terms of obtaining
complication-free healing.
Harvest of the TAP-flap allows the Latissimus Dorsi muscle to be left undissected in most
cases. When indicated a small cuff of muscle surrounding the dominating perforator can be
included in the flap or a small back cut inferiorly to the perforator can be made to allow
tension free rotation of the skin paddle. In all cases the procedure is expected to leave the
muscle function intact.
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.
The main objective of this study is to determine whether any detectable difference in
shoulder affection distinguishes these two techniques. For this purpose we have designed two
separate trials:
Retrospective Follow-up Trial This part of the study intends to examine and compare
historical data on women who have already had a delayed breast reconstruction by one of the
two methods. The main goal of this pilot study is to collect and analyse all existing
information in order to provide a sound background knowledge that should serve as basis for
the following RCT. Most importantly this study should provide sufficient data to perform an
accurate calculation of the sample size.
Randomized Clinical Trial This trial will be conducted as a confirmatory superiority trial.
The intend is to collect, examine and compare data on the two surgical techniques in order to
test superiority of the TAP-flap based reconstruction in accordance with our hypothesis as
specified above.
The trial is thus designed with two parallel study-arms as patients are allocated to
reconstruction by either LD-flap or TAP-flap in the ratio 1:1. As the clinically most
important parameter seems to be any objective change in shoulder function this will serve as
the primary end-point. Patient reported discomfort/pain as well as the need for physical
rehabilitation will also be investigated and analysed as supportive secondary end-points.
In addition to the above data on a number of other patient-related outcomes will be collected
as part of this trial. These issues will be addressed as tertiary end-points of a more
exploratory nature. We expect these data to supply useful knowledge for further
investigations in separate studies.
Designed as multicentre trial patient enrolment and all collection of data will be performed
at academic hospitals in Denmark and Norway. All Danish units specializing in plastic and
reconstructive surgery who are familiar with both techniques used in this protocol have been
invited to participate in this trial. In addition one centre in Skien, Norway, who adopted
the TAP-flap technique prior to the initiation of the trial, was invited to participate.
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.
A password protected, electronic database placed on a secure server will be established. This
database will only be accessible to the primary investigator and members of the research
group who will be involved in the analysis of data. Data are not blinded in relation to
allocated treatment.
This study will provide a better knowledge of the expected outcome of delayed breast
reconstruction, when it is performed by one of these two surgical techniques. Thus the
investigators expect that these results will help determine if the TAP-flap in combination
with ADM may represent a better and gentler method for reconstruction of the breast with
lower morbidity and better cost-effectiveness than the conventional LD-flap. In all cases the
results of this trial will enable us to provide patients with better and more objective
information, before they are subjected to delayed breast reconstruction.
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