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Secondary Breast Reconstruction With a Flap of Skin From the Back

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02169011
Recruitment Status : Completed
First Posted : June 20, 2014
Last Update Posted : August 14, 2019
University of Southern Denmark
Region of Southern Denmark
Sygehus Lillebaelt
Information provided by (Responsible Party):
Vejle Hospital

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.

Condition or disease Intervention/treatment Phase
Breast Reconstruction Procedure: Latissimus Dorsi Flap Reconstruction Procedure: TAP Flap Reconstruction Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Delayed Breast Reconstruction With Skin Flap From the Back
Actual Study Start Date : September 2013
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 31, 2019

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Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Patient Reported Discomfort [ Time Frame: 1 year ]

    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.

  2. Rehabilitation [ Time Frame: 1 year ]

    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.

Other Outcome Measures:
  1. Quality-of-life [ Time Frame: 1 year ]
    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.

  2. Socio-economics [ Time Frame: 1 year ]
    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.

  3. Aesthetic Outcome [ Time Frame: 1 year ]

    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.

  4. Complications [ Time Frame: 3 months ]
    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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02169011

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Herlev Hospital
Herlev, Denmark, 2730
Odense University Hospital
Odense, Denmark, 5000
Vejle Hospital
Vejle, Denmark, 7100
Telemark Hospital
Skien, Telemark, Norway, 3710
Sponsors and Collaborators
Vejle Hospital
University of Southern Denmark
Region of Southern Denmark
Sygehus Lillebaelt
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Study Chair: Jørn B Thomsen, MD, PhD Center Hospital Lillebaelt, Institute of Regional Health Research, University of Southern Denmark

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Responsible Party: Vejle Hospital Identifier: NCT02169011    
Other Study ID Numbers: S-20120207
First Posted: June 20, 2014    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Keywords provided by Vejle Hospital:
Breast reconstruction
Breast cancer