Perioperative Management of DIEP Flaps

University of Regensburg100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

100

Conditions

Mammaplasty Microsurgery Free Tissue Flaps

Interventions

Crystalloid SolutionsDRUG

crystalloid restrictive anesthesia protocol

CatecholaminesDRUG

catecholamine restrictive anesthesia protocol

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University hospital of Regensburg

Regensburg, Germany

RECRUITING

Outcomes

Primary Outcomes

Free flap survival rate

Rates of (partial) flap loss in each study arm

Time frame: 5 days postoperatively

Secondary Outcomes

Period of hospitalization

Length of postoperative hospitalization in each study arm

Time frame: up to 14 days

Central Contacts

Alexandra Anker, MD

CONTACT

0049 941 782 3110 aanker@caritasstjosef.de

Data from ClinicalTrials.gov

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