Preoperative Imaging in DIEP Flap Breast Reconstruction

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02111239
• Other study ID #: Sunnybrook106-2011
• Status: Active, not recruiting
• Phase: N/A
• First received: August 1, 2013
• Last updated: October 21, 2016
• Start date: June 2011
• Est. completion date: November 2017

Study information

• Verified date: October 2016
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• CTA
pelvic/abdominal CTA scan
• MRA
pelvic/abdominal MRA scan

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Canadian Breast Cancer Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Economic Outcome	The costs of medical imaging and operating expenses will be calculated and compared between study groups.	1 year	No