Clinical trial NCT02111239: Preoperative Imaging in DIEP Flap Breast Reconstruction
Official title: Preoperative Imagining in DIEP Flap Breast Reconstruction: A Randomized Controlled Trial Evaluating Cost and Patient-Reported Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: DIEP
DIEP flap
Breast reconstruction
Breast Cancer
CTA
MRA
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Canadian Breast Cancer Foundation
First posted: 2014-04-11
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time for flap dissection
timeFrame: 1 day - during surgery
measure: Change in BREAST-Q Scores
timeFrame: Preoperatively, Postoperatively at 3 weeks, 3 months, 12 months
Secondary outcomes:
measure: Whether change in operative procedure occurred during surgery
timeFrame: 1 day
measure: Change in Memorial Pain Assessment Card (MPAC) Scores
timeFrame: Baseline, postoperatively on the first 4 days, and at 3 weeks, 3 months and 12 months
measure: NASA-Task Load Index (TLX)
timeFrame: once - immediately postoperatively
measure: Economic Outcome
timeFrame: 1 year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Joan Lipa, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: