Preoperative Imaging in DIEP Flap Breast Reconstruction
Preoperative Imagining in DIEP Flap Breast Reconstruction: A Randomized Controlled Trial Evaluating Cost and Patient-Reported Outcomes
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: No imaging
No preoperative imaging is performed for this group
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Experimental: CTA
Patients randomized to this group will undergo a preoperative CTA scan.
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pelvic/abdominal CTA scan
Other Names:
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Experimental: MRA
Patients randomized to this group will undergo a preoperative MRA scan.
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pelvic/abdominal MRA scan
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time for flap dissection
Time Frame: 1 day - during surgery
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Time to reach exposure of perforators combined with time for flap elevation will be recorded during the surgical procedure.
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1 day - during surgery
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Change in BREAST-Q Scores
Time Frame: Preoperatively, Postoperatively at 3 weeks, 3 months, 12 months
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Self-administered quality of life and outcomes questionnaire for women that undergo breast reconstruction.
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Preoperatively, Postoperatively at 3 weeks, 3 months, 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Whether change in operative procedure occurred during surgery
Time Frame: 1 day
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Change of operative plan either prior to surgery as a result of preoperative imaging, or intra-operatively, will be recorded
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1 day
|
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Change in Memorial Pain Assessment Card (MPAC) Scores
Time Frame: Baseline, postoperatively on the first 4 days, and at 3 weeks, 3 months and 12 months
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Self-administered questionnaire consisting of 4 questions related to pain, pain relief, and mood.
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Baseline, postoperatively on the first 4 days, and at 3 weeks, 3 months and 12 months
|
|
NASA-Task Load Index (TLX)
Time Frame: once - immediately postoperatively
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Completed by the operating surgeon to evaluate workload based on 6 scales: mental demand, physical demand, temporal demand, performance, effort and frustration.
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once - immediately postoperatively
|
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Economic Outcome
Time Frame: 1 year
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The costs of medical imaging and operating expenses will be calculated and compared between study groups.
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1 year
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Joan Lipa, MD, MSc, Sunnybrook Health Sciences Centre
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sunnybrook106-2011
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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