Trial document




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  DRKS00012481

Trial Description

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Title

Surveillance of patient satisfaction after autologous tissue reconstruction and lipofilling of the breast (clinical and radiologic long-term outcome)

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Lipofilling is a worldwide established surgical procedure; however, its long-term outcome, indications and risks have not sufficiently been evaluated yet. Since in terms of de novo - formation of breast cancer and the impairment of radiologic diagnostics after lipofilling of the breast, no adequately documented long-term outcome has been recorded yet, we want to evaluate the locoregional recurrence rate as well as radiologic long-term outcome after lipofilling of the breast.

Thus, throughout our study, we want to evaluate the subjective take rate, the number of lipofilling sessions needed, complication rates and general satisfaction of patients who have undergone autologous tissue reconstruction with and without lipofilling.

Furthermore, we aim to analyze patient satisfaction of patients who have undergone autologous tissue reconstruction followed by mamilla-areola complex (MAC) reconstruction, evaluating different techniques of MAC-reconstruction.

Moreover, patient satisfaction and clinical/radiologic outcome after lipofilling of the breast of patients with congenital malformations such as Poland syndrome, tubular breast etc.) as well as after aesthetic mamma augmentations through lipofilling are analyzed.

Patients are contacted by a cover letter and individual patient satisfaction after autologous tissue reconstruction and lipofilling of the breast, the subjective take rate of the transplanted adipous tissue, and, in case of patients with autologous tissue reconstruction after breast cancer, the locoregional recurrence rate of breast cancer and the satisfaction with the reconstructied MAC is evaluated using a patient questionnaire.

Furthermore, patients are asked to send us a digital as well as written findings (sonography, mammography and/or MR) before and after lipofilling of the breast as well as the completed questionnaire.
The radiological findlings are evaluated by two radiologists in a blinded manner. Hereby, we aim to analyze if lipofilling of the breast impairs radiologic interpretation, resulting in false-positive suspicions of malignancy as well as higher number of recommended biopsies of the breast.

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Brief Summary in Scientific Language

Lipofilling is a worldwide established surgical procedure; however, its long-term outcome, indications and risks have not sufficiently been evaluated yet. Since in terms of de novo - formation of breast cancer and the induction of potentially residual breast cancer cells by mature adipocytes, mesenchymal stem cells of human adipous tissue or by adipocyte-derived factors or the impairment of radiologic diagnostics after lipofilling of the breast, no adequately documented long-term outcome has been recorded yet, we want to evaluate the locoregional recurrence rate as well as radiologic long-term outcome after lipofilling of the breast.

Thus, throughout our study, we want to evaluate the subjective take rate, the number of lipofilling sessions needed, complication rates and general satisfaction of patients who have undergone autologous tissue reconstruction with and without lipofilling.

Furthermore, we aim to analyze patient satisfaction of patients who have undergone autologous tissue reconstruction followed by mamilla-areola complex (MAC) reconstruction, evaluating different techniques of MAC-reconstruction.

Moreover, patient satisfaction and clinical/radiologic outcome after lipofilling of the breast of patients with congenital malformations such as Poland syndrome, tubular breast etc.) as well as after aesthetic mamma augmentations through lipofilling are analyzed.

Patients are contacted by a cover letter and individual patient satisfaction after autologous tissue reconstruction and lipofilling of the breast, the subjective take rate of the transplanted adipous tissue, and, in case of patients with autologous tissue reconstruction after breast cancer, the locoregional recurrence rate of breast cancer and the satisfaction with the reconstructied MAC is evaluated using a patient questionnaire.

Furthermore, patients are asked to send us a digital as well as written findings (sonography, mammography and/or MR) before and after lipofilling of the breast as well as the completed questionnaire.
The radiological findlings are evaluated by two radiologists in a blinded manner. Hereby, we aim to analyze if lipofilling of the breast impairs radiologic interpretation, resulting in false-positive suspicions of malignancy as well as higher number of recommended biopsies of the breast.

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Organizational Data

  •   DRKS00012481
  •   2017/06/12
  •   [---]*
  •   yes
  •   Approved
  •   EA1/082/17, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   C50 -  Malignant neoplasm of breast
  •   Q83.80 -  [generalization Q83.8: Other congenital malformations of breast]
  •   Q79.8 -  Other congenital malformations of musculoskeletal system
  •   Q83.88 -  [generalization Q83.8: Other congenital malformations of breast]
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Interventions/Observational Groups

  •   Patients who have undergone breast reconstruction / MAC reconstruction and lipofilling
  •   Patients who have undergone breast reconstruction / MAC reconstruction without lipofilling
  •   Patients with congenital malformations (Poland syndrome, tubular breast deformity, etc.) who have undergone lipofilling of the breast
  •   Patients who have undergone aesthetic mamma augmentation through lipofilling
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Non-randomized controlled trial
  •   Blinded
  •   assessor
  •   Other
  •   Other
  •   Parallel
  •   III
  •   N/A
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Primary Outcome

Evaluation of the individual patient satisfaction after autologous tissue reconstruction/MAC-reconstruktion / after lipofilling of the breast, the subjective take rate of the transplanted adipous tissue and the locoregional recurrence rate. This is evaluated once by means of a questionnaire.

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Secondary Outcome

Evaluation of a potential impairment of radiologic findings of the breast after lipofilling/ Increased rate of suggested biopsies of the breast due to the residual adipous tissue. This is evaluated once by a radiologist in a blinded manner.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2017/06/13
  •   400
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   14   Years
  •   100   Years
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Additional Inclusion Criteria

Patients who have undergone breast reconstruction / MAC reconstruction with/without lipofilling
Patients with congenital malformations (Poland syndrome, tubular breast deformity) who have undergone lipofilling of the breast
Patients with aesthetic mamma augmentation through lipofilling

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Exclusion Criteria

Patients under the age of 13

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Addresses

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    • Klinik für Plastische und Ästhetische Chirurgie, Handchirurgie, HELIOS Klinikum Emil von Behring
    • Ms.  Dr.  Alba  Fricke 
    • Walterhöferstraße 11
    • 14165  Berlin
    • Germany
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    • Klinik für Plastische und Ästhetische Chirurgie,HELIOS Klinikum Emil von Behring
    • Ms.  Dr.  Alba  Fricke 
    • Walterhöfer Str. 11
    • 14165  Berlin
    • Germany
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    • Klinik für Plastische und Ästhetische Chirurgie,HELIOS Klinikum Emil von Behring
    • Ms.  Dr.  Alba  Fricke 
    • Walterhöfer Str. 11
    • 14165  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • HELIOS Forschungsförderung - Zentrale Dienst Forschung und Wissenschaft
    • Heusnerstraße 40
    • 42283  Wuppertal
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.