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.
Procedure: Latissimus Dorsi Flap Reconstruction
Procedure: TAP Flap Reconstruction
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Delayed Breast Reconstruction With Skin Flap From the Back|
- Shoulder Function [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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.
- Patient Reported Discomfort [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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. For this the following frasing will be used:
"Have you experienced either pain, tightening or discomfort in your neck, back, arm or the reconstructed breast during the last month?"
All patients indicating any symptomatology will be asked the following:
"On a scale from 1-10, where 1 indicates the lowest level of pain or discomfort and 10 the highest, please indicate the worst level of pain or discomfort you have experienced in the past month"
A median value of the level of discomfort at each time-point will be calculated for each patient-group and tested for statistically significant difference as the most important supportive secondary end-points.
- Rehabilitation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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.
As for evaluation of the shoulder function, registration of average time spent weekly on physiotherapy/training will be made by the primary investigator in the outpatient clinic 6 and 12 months postoperatively. A median value of the time spent weekly on physiotherapy and shoulder-specific training at each time-point will be calculated for each patient-group and tested for statistically significant difference as supportive secondary end-points.
- Quality-of-life [ Time Frame: 1 year ] [ Designated as safety issue: No ]The patients' quality-of-life will be assessed before and after reconstruction using the international validated questionnaire developed The European Organisation 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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]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. Based on the data collected we will perform an evaluation of the total expenditure associated with the two different types of delayed reconstruction. This evaluation will comprise an estimate of the costs associated with the procedures including expenses for utensils, implants and ADM as well as an estimate of the expenses related to hospitalization, sick leave and rehabilitation.
- Aesthetic Outcome [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]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 explantation. Complications will be classified as either major or minor depending on the need for surgical revision.
|Study Start Date:||September 2013|
|Estimated Study Completion Date:||September 2017|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
Active Comparator: Latissimus Dorsi Flap Reconstruction
Patients are allocated to delayed breast reconstruction with the Latissimus Dorsi flap and if needed an implant.
Procedure: Latissimus Dorsi Flap Reconstruction
Delayed, unilateral breast reconstruction with the LD-flap. The reconstruction will be performed in a standard fashion as specified in the protocol. Implants should be used when required to gain sufficient volume of the breast.
Active Comparator: TAP Flap Reconstruction
Patients are allocated to delayed breast reconstruction with the TAP-flap and if needed an implant in combination with an acellular dermal matrix.
Procedure: TAP Flap Reconstruction
Delayed, unilateral breast reconstruction with the TAP-flap. The reconstruction will be performed as specified in the protocol and when implants are required to gain sufficient volume they should be combined with an acellular dermal matrix.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT02169011
|Herlev, Denmark, 2730|
|Odense University Hospital|
|Odense, Denmark, 5000|
|Vejle, Denmark, 7100|
|Skien, Telemark, Norway, 3710|
|Study Chair:||Jørn B Thomsen, MD, PhD||Center Hospital Lillebaelt, Institute of Regional Health Research, University of Southern Denmark|