Preoperative Imaging in DIEP Flap Breast Reconstruction

Not Applicable

• Conditions: Breast Cancer
• Interventions: Device: MRA; Device: CTA

• Registration Number: NCT02111239
• Lead Sponsor: Sunnybrook Health Sciences Centre

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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2013-08-01
• Study First Submitted QC: 2014-04-08
• Study First Posted: 2014-04-11
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-21
• Last Update Posted: 2016-10-24
• Primary Completion: 2017-11
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MRA	MRA	Patients randomized to this group will undergo a preoperative MRA scan.
CTA	CTA	Patients randomized to this group will undergo a preoperative CTA scan.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in Memorial Pain Assessment Card (MPAC) Scores	Baseline, postoperatively on the first 4 days, and at 3 weeks, 3 months and 12 months	Self-administered questionnaire consisting of 4 questions related to pain, pain relief, and mood.
NASA-Task Load Index (TLX)	once - immediately postoperatively	Completed by the operating surgeon to evaluate workload based on 6 scales: mental demand, physical demand, temporal demand, performance, effort and frustration.
Economic Outcome	1 year	The costs of medical imaging and operating expenses will be calculated and compared between study groups.
Whether change in operative procedure occurred during surgery	1 day	Change of operative plan either prior to surgery as a result of preoperative imaging, or intra-operatively, will be recorded

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada