Trial document





This trial has been registered retrospectively.
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  DRKS00003570

Trial Description

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Title

Oncological safety, esthetics and surgical safety after skin-sparing mastectomy using Latissimus dorsi reconstruction in patients with mamma carcinoma.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

We will analyze the complication and recurrence rate after skin-sparing breast removal using reconstruction with the big back muscle (Latissimus dorsi). After the surgery the cosmetic result will be assessed by the surgeon (Winfried Schoenegg, MD), a second person (cand. med. Sophie Stegmann), an independent physician (Friederike Siedentopf, MD) and the patient.

The main hypotheses are:
1) The sking-sparing breast removal is a safe cancer treatment.
2) The skin-sparing breast removal provides excellent cosmetic results.
The secondary hypothesis is:
1)The skin-sparing breast removal with reconstruction using the big back muscle is a safe surgical procedure.
The results we enable us to judge at what point of the treatment a skin-sparing breast removal is sensible and which patients will benefit the most.
Hence the local and distant recurrence risk will be decreased in the meantime the cosmetic results will be good.
The analysis of the complication rate permits to detect risk factors and therefore to reduce the complication rate.
Additionally we want to compare this operation technique to other already evaluated operation methods. Consequently the preoperative advice can be more efficient and easier understandable for the patient.
The patient will be better informed about the risk of recurrence, cancer spread and potential complications.

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Brief Summary in Scientific Language

Main hypothesis: 1) The skin-sparing mastectomy using Latissimus dorsi reconstruction is a safe oncological procedure.
2) The skin-sparing mastectomy provides excellent cosmetic results.
We will evaluate the oncological safety of this operation technique by analyzing the recurrence and metastasis rate. It will be necessary to see if a local recurrence and/or a metastasis occurred during the follow-up. These results will be compared with recurrence and metastasis rates of the simple mastectomy and of the skin-sparing mastectomy using other published operation techniques.
Four different persons will evaluate the cosmetic results with a standardized scale (Drucker-Zertuche et al., 2007): The surgeon (W. Schoenegg, MD), the PhD student (cand. med. Sophie Stegmann), an independent physician (F. Siedentopf, MD) and the patient. A picture of the operated breast will be taken for documentation purposes. Only the operating field will be photographed, the patient will not be recognizable.
Additionally we will analyze the surgical safety by evaluating early and late complications that occurred after surgery, such as infection, hematoma, flap necrosis, seroma and implant loss . These results will be compared with published results as well.
It will be possible to determine at what point of the treatment a a skin-sparing mastectomy with Latissimus dorsi reconstruction is sensible and which patients benefit the most from it.
It will be possible to reduce the risk of local recurrence and metastasis and to provide good esthetic results at the same time.
By analyzing the complication rate we can connect certain factors to certain complications and hence reduce the risk of complications.
In addition to that a comparison between the skin-sparing mastectomy using Latissimus dorsi reconstruction and already evaluated operation techniques can be made. Thereby the preoperative advice will be more efficient and more comprehensible for the patients. It will be possible to inform the patients better about recurrence and metastasis rate and about possible complications.

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Organizational Data

  •   DRKS00003570
  •   2012/05/07
  •   [---]*
  •   yes
  •   Approved
  •   EA4/128/11, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  •   U1111-1128-2929 
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Health Condition or Problem studied

  •   C50 -  Malignant neoplasm of breast
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Interventions/Observational Groups

  •   Patients treated with skin-sparing mastectomy using Latissimus dorsi reconstruction at the Breast Center of the DRK-Kliniken-Westend or at Dr. Schoenegg's practice will be questioned once about their satisfaction with the surgical results. In addition to that, the surgeon (W. Schoenegg, MD), a second person (cand. med. Sophie Stegmann) and an independent physician (Dr. F. Siedentopf) will assess the surgical result. A standardized scale (Drucker-Zertuche et al. 2007) will be used for the evaluation.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The primary endpoint is the oncological safety which will be evaluated by the recurrence and metastasis rate. We will use the patient's records.
The observation period is : 1-19 years

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Secondary Outcome

The surgical safety will be evaluated by the complication rate. Complications are for example hematoma, infections, implant loss.
The esthetic results will be assessed using questionnaires following the design of Drucker-Zertuche et al.
It deals with five different aspects of the reconstructed breast:

1.Shape of the reconstructed breast compared to the not reconstructed breast. a)Very satisfied b)satisfied c)moderatly satisfied d)not satisfied

2. Size of the reconstructed breast compared to the not reconstructed breast. a)Very satisfied b)satisfied c)moderatly satisfied d)not satisfied

3.Mobility of the reconstructed breast compared to the not reconstructed breast. a) normal mobility b)a little bit less mobile c)a lot less mobile d)not mobile

4. Consistency of the reconstructed breast compared to the not reconstructed breast. a) soft b)a little bit less soft c)firm d)hard

5. Scar tissue a)No scar tissue or hypertrophy b)thin scars or hypertrophy c)moderate scars or hypertrophy d)obvious scars or hypertrophy

Time of measurement: one time evaluation 1-20 years after surgery

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2012/03/31
  •   120
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Female mamma carcinoma patients treated with skin-sparing mastectomy and reconstruction using the Latissimus dorsi flap. The operation has to be performed at the DRK-Kliniken-Westend or at Dr. Schoenegg's practice.

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Exclusion Criteria

Patients who do not speak the german are excluded.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Brustzentrum DRK-Kliniken Westend
    • Mr.  Dr.  Winfried  Schoenegg 
    • Spandauer Damm 130
    • 14050  Berlin
    • Germany
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    • Brustzentrum DRK-Kliniken Westend
    • Mr.  Dr.  Winfried  Schoenegg 
    • Spandauer Damm 130
    • 14050  Berlin
    • Germany
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    • Brustzentrum DRK-Kliniken Westend
    • Mr.  Dr.  Winfried  Schoenegg 
    • Spandauer Damm 130
    • 14050  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Brustzentrum DRK-Kliniken Westend
    • Mr.  Dr.  Winfried  Schoenegg 
    • Spandauer Damm 130
    • 14050  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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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.