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Preoperative Imaging in DIEP Flap Breast Reconstruction

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
CTA
MRA
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring DIEP, DIEP flap, Breast reconstruction, Breast Cancer, CTA, MRA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

No imaging

CTA

MRA

Arm Description

No preoperative imaging is performed for this group

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

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

Outcomes

Primary Outcome Measures

Time for flap dissection
Time to reach exposure of perforators combined with time for flap elevation will be recorded during the surgical procedure.
Change in BREAST-Q Scores
Self-administered quality of life and outcomes questionnaire for women that undergo breast reconstruction.

Secondary Outcome Measures

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

Full Information

First Posted
August 1, 2013
Last Updated
October 21, 2016
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Canadian Breast Cancer Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02111239
Brief Title
Preoperative Imaging in DIEP Flap Breast Reconstruction
Official Title
Preoperative Imagining in DIEP Flap Breast Reconstruction: A Randomized Controlled Trial Evaluating Cost and Patient-Reported Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
November 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Canadian Breast Cancer Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
DIEP, DIEP flap, Breast reconstruction, Breast Cancer, CTA, MRA

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No imaging
Arm Type
No Intervention
Arm Description
No preoperative imaging is performed for this group
Arm Title
CTA
Arm Type
Experimental
Arm Description
Patients randomized to this group will undergo a preoperative CTA scan.
Arm Title
MRA
Arm Type
Experimental
Arm Description
Patients randomized to this group will undergo a preoperative MRA scan.
Intervention Type
Device
Intervention Name(s)
CTA
Other Intervention Name(s)
preoperative CTA, computed tomography angiography
Intervention Description
pelvic/abdominal CTA scan
Intervention Type
Device
Intervention Name(s)
MRA
Other Intervention Name(s)
preoperative MRA, magnetic resonance angiogram
Intervention Description
pelvic/abdominal MRA scan
Primary Outcome Measure Information:
Title
Time for flap dissection
Description
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
Title
Change in BREAST-Q Scores
Description
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 Outcome Measure Information:
Title
Whether change in operative procedure occurred during surgery
Description
Change of operative plan either prior to surgery as a result of preoperative imaging, or intra-operatively, will be recorded
Time Frame
1 day
Title
Change in Memorial Pain Assessment Card (MPAC) Scores
Description
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
Title
NASA-Task Load Index (TLX)
Description
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
Title
Economic Outcome
Description
The costs of medical imaging and operating expenses will be calculated and compared between study groups.
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan Lipa, MD, MSc
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

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Preoperative Imaging in DIEP Flap Breast Reconstruction

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