Preoperative Imaging in DIEP Flap Breast Reconstruction

Preoperative Imagining in DIEP Flap Breast Reconstruction: A Randomized Controlled Trial Evaluating Cost and Patient-Reported Outcomes

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Device: CTA; Device: MRA

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: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

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)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No imaging; No preoperative imaging is performed for this group
Experimental: CTA; Patients randomized to this group will undergo a preoperative CTA scan.	Device: CTA; pelvic/abdominal CTA scan; Other Names: preoperative CTA; computed tomography angiography
Experimental: MRA; Patients randomized to this group will undergo a preoperative MRA scan.	Device: MRA; pelvic/abdominal MRA scan; Other Names: preoperative MRA; magnetic resonance angiogram

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time for flap dissection	Time to reach exposure of perforators combined with time for flap elevation will be recorded during the surgical procedure.	1 day - during surgery
Change in BREAST-Q Scores	Self-administered quality of life and outcomes questionnaire for women that undergo breast reconstruction.	Preoperatively, Postoperatively at 3 weeks, 3 months, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 day
Change in Memorial Pain Assessment Card (MPAC) Scores	Self-administered questionnaire consisting of 4 questions related to pain, pain relief, and mood.	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.	once - immediately postoperatively
Economic Outcome	The costs of medical imaging and operating expenses will be calculated and compared between study groups.	1 year

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: Canadian Breast Cancer Foundation
• Investigators: Principal Investigator: Joan Lipa, MD, MSc, Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Anticipated): November 1, 2017
• Study Completion (Anticipated): November 1, 2017

Study Registration Dates

• First Submitted: August 1, 2013
• First Submitted That Met QC Criteria: April 8, 2014
• First Posted (Estimate): April 11, 2014

Study Record Updates

• Last Update Posted (Estimate): October 24, 2016
• Last Update Submitted That Met QC Criteria: October 21, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Breast Cancer; DIEP; DIEP flap; Breast reconstruction; CTA; MRA
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: Sunnybrook106-2011

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No