Breast Cancer
Conditions
Keywords
DIEP, DIEP flap, Breast reconstruction, Breast Cancer, CTA, MRA
Brief summary
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
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.
Sponsors
Canadian Breast Cancer Foundation
Sunnybrook Health Sciences Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time for flap dissection | 1 day - during surgery | Time to reach exposure of perforators combined with time for flap elevation will be recorded during the surgical procedure. |
| Change in BREAST-Q Scores | Preoperatively, Postoperatively at 3 weeks, 3 months, 12 months | Self-administered quality of life and outcomes questionnaire for women that undergo breast reconstruction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NASA-Task Load Index (TLX) | once - immediately postoperatively | Completed by the operating surgeon to evaluate workload based on 6 scales: mental demand, physical demand, temporal demand, performance, effort and frustration. |
| Economic Outcome | 1 year | The costs of medical imaging and operating expenses will be calculated and compared between study groups. |
| Whether change in operative procedure occurred during surgery | 1 day | Change of operative plan either prior to surgery as a result of preoperative imaging, or intra-operatively, will be recorded |
| Change in Memorial Pain Assessment Card (MPAC) Scores | Baseline, postoperatively on the first 4 days, and at 3 weeks, 3 months and 12 months | Self-administered questionnaire consisting of 4 questions related to pain, pain relief, and mood. |
Countries
Canada
Outcome results
None listed