Preoperative Imaging in DIEP Flap Breast Reconstruction

NCT ID: NCT02111239

Last Updated: 2016-10-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2017-11-30

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

No imaging

No preoperative imaging is performed for this group

Group Type: NO_INTERVENTION

No interventions assigned to this group

CTA

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

Group Type: EXPERIMENTAL

CTA

Intervention Type: DEVICE

pelvic/abdominal CTA scan

MRA

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

Group Type: EXPERIMENTAL

MRA

Intervention Type: DEVICE

pelvic/abdominal MRA scan

Interventions

CTA

pelvic/abdominal CTA scan

Intervention Type: DEVICE

MRA

pelvic/abdominal MRA scan

Intervention Type: DEVICE

Other Intervention Names

preoperative CTA; computed tomography angiography; preoperative MRA; magnetic resonance angiogram

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Canadian Breast Cancer Foundation

OTHER

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joan Lipa, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

Sunnybrook106-2011

Identifier Type: -

Identifier Source: org_study_id