Preoperative Imaging in DIEP Flap Breast Reconstruction

Sunnybrook Health Sciences Centre60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

CTADEVICE

pelvic/abdominal CTA scan

MRADEVICE

pelvic/abdominal MRA scan

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Time for flap dissection

Time to reach exposure of perforators combined with time for flap elevation will be recorded during the surgical procedure.

Time frame: 1 day - during surgery

Change in BREAST-Q Scores

Self-administered quality of life and outcomes questionnaire for women that undergo breast reconstruction.

Time frame: Preoperatively, Postoperatively at 3 weeks, 3 months, 12 months

Secondary Outcomes

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

Time frame: 1 day

Change in Memorial Pain Assessment Card (MPAC) Scores

Self-administered questionnaire consisting of 4 questions related to pain, pain relief, and mood.

Time frame: 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.

Time frame: once - immediately postoperatively

Economic Outcome

The costs of medical imaging and operating expenses will be calculated and compared between study groups.

Time frame: 1 year

Data from ClinicalTrials.gov

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