Secondary arm lymphedema following treatment for breast cancer and its prevention in the context of microsurgical breast reconstruction. I97.2
Conditions
Interventions
Group 1: IMV Group – Anastomosis to the internal mammary artery and vein (internal mammary vessels) – Data collection at 5 time points (preoperative, Day 6, 6/12/24 months postoperative) using validat
Sponsors
Department für Frauengesundheit
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: - Written informed consent - Completed primary curative treatment for breast cancer (with the exception of ongoing anti-hormonal therapy) - Following unilateral breast-conserving surgery or mastectomy (with or without prior reconstruction) with axillary intervention (sentinel lymph node biopsy [SNB] or axillary lymph node dissection [aLNE]) - Planned microsurgical breast reconstruction using autologous tissue (DIEP or FCI), in which the anastomosis is to be performed on axillary vessels or on the internal mammary artery and vein
Exclusion criteria
Exclusion criteria: - Expected lack of compliance or limited capacity to provide informed consent - Lack of written consent to participate in the study - Planned or ongoing oncological therapy during the observation period due to tumor recurrence (chemotherapy, radiation, or surgical re-intervention) - Pre-existing severe deformities of the affected limb or thorax that limit the standardized performance of measurements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is the effect of the anatomical location of the anastomosis (axilla vs. internal thoracic artery) on the postoperative quality of life of patients following microsurgical reconstruction, as measured using the validated BREAST-Q questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Subcutaneous tissue changes – sonographic measurement of skin/subcutaneous tissue thickness using a high-frequency linear probe (12–18 MHz) at 4 defined measurement points (back of the hand, forearm, upper arm, lateral chest), on both sides, as a relative ratio to the opposite side. 2. Arm circumference – Circumference measurement with a measuring tape at 4 defined locations (upper arm, forearm, wrist, metacarpus), bilaterally while seated. 3. Postoperative complications and revision surgeries – standardized documentation (dehiscence, infection, seroma, hematoma, liponecrosis, total necrosis) as part of clinical follow-up care. | — |
Countries
Germany
Contacts
Public ContactJannik Kandzi
Department für Frauengesundheit
Outcome results
None listed