Autologous Deep Inferior Epigastric Perforator (DIEP) Flap Breast Reconstruction: Comparison of arterial End-to-Side versus End-to-End Anastomosis
Not Applicable
Recruiting
- Conditions
- Autologous DIEP flap breast reconstruction following mastectomy as part of breast cancer therapy.
- Registration Number
- DRKS00032948
- Lead Sponsor
- BG Klinik Ludwigshafen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 60
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Major surgical complication of the recipient (i.e. breast) site, defined as the occurrence of any of the following:<br>a)Microsurgical complications: anastomotic insufficiency, arterial thrombosis<br>b)Hematoma<br>c)Partial or total flap loss <br>d)Reoperation for any of the above and for, but not limited to, wound dehiscence, necrosis, infection<br>
- Secondary Outcome Measures
Name Time Method 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<br><br>Major surgical complication of the donor (i.e. abdominal) site, defined as the occurrence of any of the following:<br>a)Skin or adipose tissue necrosis<br>b)Wound dehiscence<br>c)Hematoma<br>d)Seroma<br>e)Hernia or abdominal bulge<br>f)Infection<br>g)Reoperation for, but not limited to, any of the above <br><br>Patient satisfaction, measured using the: <br>a)SF-36 <br>b)BREAST-Q (reconstruction module)<br>before and 12 months after surgery<br>