Preoperative Imaging in DIEP Flap Breast Reconstruction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Preoperative Imagining in DIEP Flap Breast Reconstruction: A Randomized Controlled Trial Evaluating Cost and Patient-Reported Outcomes

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: CTA
* Device: MRA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: candidate for DIEP flap breast reconstruction speak/read/write English have undergone or will undergo unilateral or bilateral mastectomy Exclusion Criteria: previous abdominal surgery that may preclude a DIEP flap reconstruction active smoker BMI over 35 severe claustrophobia sensitivity to intravenous CT contrast medium (Visipaque 320) or MR contrast medium (Gadovist 1.0) urgency of surgery that precludes study enrollment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No imaging<br>No preoperative imaging is performed for this group | |
| Experimental: CTA<br>Patients randomized to this group will undergo a preoperative CTA scan. | Device: CTA<br>* pelvic/abdominal CTA scan<br>* Other names: computed tomography angiography;|
| Experimental: MRA<br>Patients randomized to this group will undergo a preoperative MRA scan. | Device: MRA<br>* pelvic/abdominal MRA scan<br>* Other names: magnetic resonance angiogram;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time for flap dissection | Time to reach exposure of perforators combined with time for flap elevation will be recorded during the surgical procedure. | 1 day - during surgery | 
| Change in BREAST-Q Scores | Self-administered quality of life and outcomes questionnaire for women that undergo breast reconstruction. | Preoperatively, Postoperatively at 3 weeks, 3 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whether change in operative procedure occurred during surgery | Change of operative plan either prior to surgery as a result of preoperative imaging, or intra-operatively, will be recorded | 1 day | 
| Change in Memorial Pain Assessment Card (MPAC) Scores | Self-administered questionnaire consisting of 4 questions related to pain, pain relief, and mood. | Baseline, postoperatively on the first 4 days, and at 3 weeks, 3 months and 12 months | 
| NASA-Task Load Index (TLX) | Completed by the operating surgeon to evaluate workload based on 6 scales: mental demand, physical demand, temporal demand, performance, effort and frustration. | once - immediately postoperatively | 
| Economic Outcome | The costs of medical imaging and operating expenses will be calculated and compared between study groups. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRA, DIEP, DIEP flap, Breast reconstruction, Breast Cancer, CTA