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Clinical Trials/NCT02169011
NCT02169011CompletedNot Applicable

Delayed Breast Reconstruction With Skin Flap From the Back

Vejle Hospital8 sites in 2 countries50 target enrollmentStarted: September 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
8
Primary Endpoint
Shoulder Function

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Shoulder Function

Time Frame: 1 year

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 system assess pain, function in everyday-life, range of motion and strength and incorporates these parameters into one total score. It is the recommended scoring-system by the European Society of Shoulder and Elbow Surgery. Each variable in the system is evaluated separately. For all patients scoring will be performed preoperatively as well as 3, 6 and 12 months postoperatively. Shoulder function will be evaluated bilaterally at all stages. To avoid multiplicity-issues the primary end-point has been defined as the difference in the total score between the baseline evaluation preoperatively and the evaluation one year postoperatively.

Secondary Outcomes

  • Rehabilitation(1 year)
  • Patient Reported Discomfort(1 year)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (8)

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