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| Name | Class |
|---|---|
| Canadian Breast Cancer Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No imaging | No Intervention | No preoperative imaging is performed for this group | |
| CTA | Experimental | Patients randomized to this group will undergo a preoperative CTA scan. |
|
| MRA | Experimental | Patients randomized to this group will undergo a preoperative MRA scan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTA | Device | pelvic/abdominal CTA scan |
|
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joan Lipa, MD, MSc | Sunnybrook Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 25, 2019 | |
| Unrelease | Apr 29, 2019 | |
| Release | Apr 30, 2019 | |
| Reset | Jul 16, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 25, 2019 | Apr 29, 2019 | |||
| Apr 30, 2019 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000072226 | Computed Tomography Angiography |
| D018810 | Magnetic Resonance Angiography |
| ID | Term |
|---|---|
| D014057 | Tomography, X-Ray Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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| MRA | Device | pelvic/abdominal MRA scan |
|
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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 |
| Jul 16, 2019 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D003933 | Diagnosis |
| D064847 | Multimodal Imaging |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D014054 | Tomography |
| D008279 | Magnetic Resonance Imaging |
| D000792 | Angiography |
| D003935 | Diagnostic Techniques, Cardiovascular |