Health TrialsbyHealthPanel

AFT: Introduction of a Full Breast Reconstructive Method

ConditionsBreast CancerReconstructive SurgeryBreast Reconstruction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorMaastricht University Medical Center

About this trial

A multicentre prospective cohort study will monitor the efficacy and safety of Autologous Fat Transfer (AFT) with pre-expansion. AFT will be evaluated in terms of quality of life, aesthetic result, complications, oncological safety and cost-effectiveness. It follows the BREAST trial, the randomised controlled trial comparing AFT with implant-based reconstruction. In this study, patients all receive AFT.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female gender

Age of 18 years and older

History or in candidate for a mastectomy procedure in the near future

Patients undergoing preventive mastectomy

Disqualifiers

Active smoker or a history of smoking 4 weeks prior to surgery

Current substance abuse

History of lidocaine allergy

History of silicone allergy

Trial population

Breast cancer patients or women who, due to a gene mutation have a significantly high risk of developing breast cancer, decide to undergo profylactic mastectomy.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Autologous Fat Transfer

    Procedure/Surgery

    Female breast cancer patients who were surgically treated with mastectomy could opt for a full breast reconstruction with Autologous Fat Transfer in combination with external expansion.

Treatment groups

350 Participants
are divided into 1 treatment group
Group A: Autologous Fat Transfer1 intervention

Trial outcomes

Primary outcomes

1

Breast-related Quality of life

Measured by the BREAST-Q questionnaire (quality of life subdivision)

Time frame
2 years

Secondary outcomes

1

Aesthetic result

The overall aesthetic result will be measured using 3D-photographs which will be assessed by a panel of independent plastisch surgeons, ex-breast cancer patients and healthy volunteers. In addition, the volume, shape and symmetry will be assessed by the patient using the BREAST-Q questionnaire (satisfaction with breasts subdivisions).

Time frame
2 years
2

Complications

Measurement of short-term als well as mid-term complications associated with procedures as well as (serious) adverse events.

Time frame
2 years
3

Oncological safety

Oncological follow-up will comply to the guidelines for breast cancer and will take place by a yearly consult with the oncological surgeon (including physical examination and mammography/ultrasound/MRI) for 5 years postoperatively. All (loco)regional and distant recurrences will be recorded.

Time frame
5 years
4

Cost-effectiveness

Cost-effectiveness analysis to determine the intramural and socio-economic costs associated with the breast reconstruction treatment.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Maastricht University Medical Center

Lead sponsor

ZonMw: The Netherlands Organisation for Health Research and Development

Collaborator

Source ClinicalTrials.gov
Apply now