Preoperative Imaging in DIEP Flap Breast Reconstruction

Sunnybrook Health Sciences Centre

Status: Unknown

Conditions: Breast Cancer

Treatments: Device: CTA; Device: MRA

Study type: Interventional

Funder types: Other

Identifiers

NCT02111239

Sunnybrook106-2011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

No imaging

No Intervention group

Description:

No preoperative imaging is performed for this group

CTA

Experimental group

Description:

Patients randomized to this group will undergo a preoperative CTA scan.

Treatment:

Device: CTA

MRA

Experimental group

Description:

Patients randomized to this group will undergo a preoperative MRA scan.

Treatment:

Device: MRA