Autologous DIEP flap breast reconstruction following mastectomy as part of breast cancer therapy.
Conditions
Interventions
Group 1: Control intervention:
End-to-End anastomosis of the DIEP-flap artery and the internal mammary artery (IMA)
Group 2: Experimental intervention:
End-to-Side anastomosis of the DIEP-flap arte
Sponsors
BG Klinik Ludwigshafen
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 18 years of age or above, Ability to communicate, Ability to understand the nature and individual consequences of the study,Complete written informed consent, Unilateral Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction planned, History of breast cancer with mastectomy or prophylactic mastectomy
Exclusion criteria
Exclusion criteria: Patient has a legal guardian, Bilateral DIEP flap planned, History of blood clotting disorder, History of thrombosis-promoting secondary diseases (vasculitis, collagenosis), History of pulmonary embolism/thrombosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major surgical complication of the recipient (i.e. breast) site, defined as the occurrence of any of the following: a)Microsurgical complications: anastomotic insufficiency, arterial thrombosis b)Hematoma c)Partial or total flap loss d)Reoperation for any of the above and for, but not limited to, wound dehiscence, necrosis, infection | — |
Secondary
| Measure | Time frame |
|---|---|
| Abdominal perfusion, calculated as the: relative difference between the preoperative and postoperative NIR perfusion Index and StO2% (day 1,3 and 5) measured with hyperspectral imaging Major surgical complication of the donor (i.e. abdominal) site, defined as the occurrence of any of the following: a) Skin or adipose tissue necrosis b) Wound dehiscence c) Hematoma d) Seroma e) Hernia or abdominal bulge f) Infection g) Reoperation for, but not limited to, any of the above Patient satisfaction, measured using the: a) SF-36 b) BREAST-Q (reconstruction module) before and 12 months after surgery | — |
Countries
Germany
Contacts
Public ContactAmir Bigdeli
BG Klinik Ludiwgshafen
Outcome results
None listed