Mammaplasty Clinical Trial
Official title:
Perioperative Management of Deep Inferior Epgastric Perforator (DIEP) Flap for Breast Reconstruction
By comparison of two different protocols with diverse fluid/ catecholamine administration limits (fluid restriction vs. catecholamine restriction with target systolic blood pressure > 100 mmHg) the investigators would like to reveal the impact of intraoperative blood pressure management on the survival rate of free deep inferior epigastric artery flaps for breast reconstruction.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | March 2019 |
Est. primary completion date | March 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion criteria: - Informed consent for study participation - Every patient undergoing breast reconstruction (primary and secondary reconstruction) with deep inferior epigastric perforator flap at our hospital is offered to participate in the study Exclusion criteria: - No informed consent for study participation - Patients with a high thromboembolic risk profile - During pregnancy and breastfeeding - Minors - Patients with a health care proxy |
Country | Name | City | State |
---|---|---|---|
Germany | University hospital of Regensburg | Regensburg |
Lead Sponsor | Collaborator |
---|---|
University of Regensburg |
Germany,
Eley KA, Young JD, Watt-Smith SR. Epinephrine, norepinephrine, dobutamine, and dopexamine effects on free flap skin blood flow. Plast Reconstr Surg. 2012 Sep;130(3):564-70. doi: 10.1097/PRS.0b013e31825dbf73. — View Citation
Motakef S, Mountziaris PM, Ismail IK, Agag RL, Patel A. Emerging paradigms in perioperative management for microsurgical free tissue transfer: review of the literature and evidence-based guidelines. Plast Reconstr Surg. 2015 Jan;135(1):290-9. doi: 10.1097/PRS.0000000000000839. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Free flap survival rate | Rates of (partial) flap loss in each study arm | 5 days postoperatively | |
Secondary | Period of hospitalization | Length of postoperative hospitalization in each study arm | up to 14 days |
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