Breast Cancer Clinical Trial
Official title:
Preoperative Imagining in DIEP Flap Breast Reconstruction: A Randomized Controlled Trial Evaluating Cost and Patient-Reported Outcomes
The purpose of this study is to determine whether preoperative abdominal imaging using either CT angiogram (CTA), or MR angiogram (MRA) will impact perforator dissection time, cost, and patient outcomes in DIEP flap breast reconstruction.
This study will prospectively compare the clinical, economic and patient outcomes of
preoperative imaging using either CTA or MRA with those of no preoperative imaging in
patients undergoing deep inferior epigastric perforator (DIEP) flap breast reconstruction.
Subjects will randomly undergo either a CTA scan or an MRA scan, or no scan (control)
preoperatively. An operative plan based on perforator size and course will be devised by an
interventional radiologist and a plastic surgeon. The DIEP flap procedure will be planned
for controls.
Subjects will not be told if the operative plan is changed intraoperatively. Flap dissection
time and changes in operative plan will be recorded intraoperatively and surgeon stress will
be evaluated following surgery. Pain and narcotic use will be evaluated preoperatively and
on days 1-4 postoperatively. The Breast-Q will be completed preoperatively and at 3 weeks, 3
months and 12 months postoperatively. Groups will be compared in terms of all variables
measured.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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