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"De novo" breast reconstruction with autologuos fat grafting in post-mastectomy patients

Organizational Data

DRKS-ID:
DRKS00004234
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2012-07-06
Last update in DRKS:
2012-07-06
Registration type:
Retrospective

Acronym/abbreviation of the study

No Entry

URL of the study

No Entry

Brief summary in lay language

In this multicenter -trial was carried out in 4 European institutions in the field of Plastic Surgery. Patients were included after the loss of the breast due to history of brest cancer. A stepwise reconstruction of the breast with autologous lipotransfer (from the upper leg or abdominal region) was achieved after mean 4 to 6 interventions. Up to date there is poor literature aboout complete breast reconstruction with this method. The aim of the study was an establishement of a stardadized protocol in oncologic patients for breast reconstruction with this surgical technique.

Brief summary in scientific language

A retrospective multicenter trial (Germany, Finland, France, Italy) was performed in order to install a protcol for complete breast reconstruction with autologous fat grafting after total uni - or bilateral mastectomy. Inclusion criteria were fullfilled by 28 patients (32 breast). In total 113 interventions with 135 grafting procedure with water assistenting liposuction (BEAULI -Method) were carried out. During follow-up period only 2,9% liponecrosis, 0,74% granuloma and 0,74% infection were detected. No significant or unaspected side effects were detected. Patients were discharged the same day or stayed simply overnight for monitoring. High patients satifaction was determined with a 10-point-Linkert scale questionnaire. Aesthetic outcome was evaluated from two board listed blinded plastic surgeons. We observed an upward trend of this reconstruvtive technique, however few literature and experience in oncoplasty exists.

Health condition or problem studied

ICD10:
C50.9 - Breast, unspecified
Free text:
Post-mastectomy (uni- or bilateral) condition, scar contracture, scar fibrosis
ICD10:
Z42.9 - Follow-up care involving plastic surgery, unspecified
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Free fat transfer with waterjet assisted liposuction for complete breast reconstruction after total mastectomy. On average 4 to 7 procedures were required, mean operation time 60min, additional operative techniques (like NAC reconstruction) were carried out simultaneously. Interval between procedures was at least 3 months. Follow - up after 6 months with clinical examination, foto documentary, control of the weight, questionnaire and radiological evaluation (mammography or sonograohy). Patients satisfaction was obtained by 10-point-Linkert scale. Aesthetic outcome was evaluated by 2 blinded board listed plastic suregeons on a 5-point- scale.

Endpoints

Primary outcome:
1) Complete breast reconstruction with autologous waterjet assisted lipotransfer : evaluation of the patient chart, duration of the reconstructive treatment, single procedure time, single and total fat volumes grafted, additional reconstructions 2) method's safety: at least 6 months follow-up, mammography or sonography,control of weight changes, foto documentary 3) patients satisfaction after completed breast reconstruction (at least 6 months): 10-point Linkert scale (3 questions) and optional comments. 4) Aesthetic results: 2 blinded board listed plastic surgeons used a 5-point ranking scale to evalute the digital fotos (pre and after)
Secondary outcome:
Improvement of the scar : clinical examination during follow-up regarding texture, color, softness.

Study Design

Purpose:
Treatment
Retrospective/prospective:
No Entry
Study type:
Non-interventional
Longitudinal/cross-sectional:
No Entry
Study type non-interventional:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Finland
  • France
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • Medical center Park-Klinik Birkenwerder, Fachklinik für Plastisch und Ästhetische Chirurgie Birkenwerder bei Berlin
  • Medical center Klinikka 22 Helsinki, Finnland
  • Medical center Clinique Saint Antoine Bois Guillaume, Frankreich
  • University medical center Helsingin seudun yliopistollinen keskussairaala Helsinki, Finnland

Recruitment period and number of participants

Planned study start date:
2012-02-18
Actual study start date:
2012-02-18
Planned study completion date:
No Entry
Actual Study Completion Date:
2012-06-15
Target Sample Size:
50
Final Sample Size:
28

Inclusion Criteria

Sex:
Female
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
Non-smokers, BMI<30, history of invasive breast cancer and total mastectomy (uni - or bilateral), end of primary therapy (irradiation or chemotherapy) for at least 2 months befor reconstruction start, denial of conservative reconstruction methods (flap - or implant based), inclusion in at least 6 months follow-up period after accomplishment of reconstruction

Exclusion Criteria

Comorbidities: diabetes, smoking, adipositas with BMI>30, wight changes >5kg pre and post treatment, prior flap-based reconstruction, breast saving mastectomy, partial mastectomy, implants in situ, incompleted reconstruction

Addresses

Primary Sponsor

Park - Klinik Birkenwerder
Dr.med. Klaus Ueberreiter
Hubertusstraße 22
16547 Birkenwerder
Germany
Telephone:
033035134000-0
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Park - Klinik Birkenwerder Fachklinik für Plastische und Ästhetische Chirurgie
Dr. med. Delia Letizia Hoppe
Hubertusstraße 22
16457 Birkenwerder
Germany
Telephone:
03303- 5134000-12
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Park - Klinik Birkenwerder
Dr.med. Klaus Ueberreiter
Hubertusstraße 22
16547 Birkenwerder
Germany
Telephone:
033035134000-0
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Park - Klinik Birkenwerder Fachklinik für Plastische und Ästhetische Chirurgie
Dr. med. Delia Letizia Hoppe
Hubertusstraße 22
16457 Birkenwerder
Germany
Telephone:
03303- 5134000-12
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Park - Klinik Birkenwerder
Hubertusstraße 22
16547 Birkenwerder
Germany
Telephone:
033035134000-0
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
No Entry
Ethics committee number:
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Vote of the Ethics Committee:
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Date of the vote:
No Entry

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
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Study abstract:
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Other study documents:
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Background literature:
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Related DRKS studies:
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Publication of study results

Planned publication:
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Publikationen/Studienergebnisse:
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Date of first publication of study results:
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DRKS entry published for the first time with results:
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Basic reporting

Basic Reporting / Results tables:
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Brief summary of results:
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