- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01469494
Breast and Abdominal Related Morbidity of DIEP and SIEA Flaps
A Randomized Clinical Trial Comparing Breast and Abdominal Related Morbidity of DIEP and SIEA Flaps
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Manitoba
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Winnipeg, Manitoba, Canada, R3A 149
- Health Sciences Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- female subject older than 18
- with satisfactory abdominal tissue for DIEP and SIEA flap reconstruction
- fluent in English
Exclusion Criteria:
- reconstruction planned using latissimus dorsi flap, gluteal artery perforator flap or tissue expansion
- suffer from neurological back problems
- suffer form inguinal hernias
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: DIEP flap group
The standard of care for the patient population is the DIEP or SIEA flap breast reconstruction.
Currently the single operating surgeon in the study will always try to perform a SIEA flap reconstruction.
If the anatomy does not allow it he will convert to a DIEP flap.
The majority of breast surgeons in North America will generally perform a DIEP flap initially.
The proposed study does not alter the standard of care received.
|
DIEP stands for deep inferior epigastric perforator.
This is the name of the main blood vessel that runs through the abdominal tissue that will be used to reconstruct the breast.
In DIEP flap reconstruction, only skin, fat, and blood vessels are removed from the lower belly (the abdomen between the waist and hips).
No muscle is removed.
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Active Comparator: SIEA flap group
The standard of care for the patient population is the DIEP or SIEA flap breast reconstruction.
Currently the single operating surgeon in the study will always try to perform a SIEA flap reconstruction.
If the anatomy does not allow it he will convert to a DIEP flap.
The majority of breast surgeons in North America will generally perform a DIEP flap initially.
The proposed study does not alter the standard of care received.
|
The SIEA flap is very similar to the DIEP flap procedure. Both techniques use the lower abdominal skin and fatty tissue to reconstruct a natural, soft breast following mastectomy. The main difference between the SIEA flap and the DIEP flap is the artery used to supply blood flow to the new breast. The SIEA blood vessels are found in the fatty tissue just below skin whereas the DIEP blood vessels run below and within the abdominal muscle (making the surgery more technically challenging). While the surgical preparation is slightly different, both procedures spare the abdominal muscle and only use the patient's skin and fat to reconstruct the breast. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in objective isokinetic abdominal strength
Time Frame: pre-operative (baseline), 3, 6 and 12 months post-operative
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Strength of the abdominal muscles and the back extensors is being objectively measured by isokinetic strength testing on an isokinetic dynamometer (Biodex System III with dual position back extension/flexion attachment).
The abdominal strength testing is being performed pre-operatively and at 3, 6 and 12 months post-op.
Objective measurements are used to address the strength of the rectus abdominus muscle and all data is collected by personnel at PanAn Clinic who have been trained in the required techniques.
The technician performing the assessments is blinded to the type of breast reconstruction that has been performed.
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pre-operative (baseline), 3, 6 and 12 months post-operative
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Breast-Q questionnaire
Time Frame: pre-operative (baseline) and 3 and 12 months post-operative
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self-administered and validated.
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pre-operative (baseline) and 3 and 12 months post-operative
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Fat Necrosis
Time Frame: 3 and 6 months post-operative
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Will be detected using ultrasonography.
Ultrasound characteristics of fat necrosis are quite variable and reflect the degree of fibrosis.
Assessment for fat necrosis will take place both 3 and 6 months post-operatively by another plastic surgeon who is therefore blinded to the procedure performed.
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3 and 6 months post-operative
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Seroma Rate and Drainage Volumes
Time Frame: 1 week post-op, 2 weeks post-op, 6-8 weeks post-op and 3 months post-op
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Rates will be tabulated and drainage volumes will be measured during regular followup appointments with the care team (1 week post-op, 2 weeks post-op, 6-8 weeks post-op, 3 months post-op).
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1 week post-op, 2 weeks post-op, 6-8 weeks post-op and 3 months post-op
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Flap Loss
Time Frame: 1 week post-op, 2 weeks post-op, 6-8 weeks post-op and 3 months post-op
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Partial flap loss defined as tissue loss greater than 10 percent of the flap or fat necrosis greater than 5cm in diameter.
Total flap loss will also be assessed.
These assessments will be done during regular followup appointments with the care team (1 week post-op, 2 weeks post-op, 6-8 weeks post-op, 3 months post-op)
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1 week post-op, 2 weeks post-op, 6-8 weeks post-op and 3 months post-op
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Abdominal Wound Breakdown
Time Frame: 1 week post-op, 2 weeks post-op, 6-8 weeks post-op and 3 months post-op
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Defined as necrosis or wound dehiscence resulting in an open wound.
Will be assessed with calipers.
This will be assessed during regular followup appointments with the care team (1 week post-op, 2 weeks post-op, 6-8 weeks post-op, 3 months post-op)
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1 week post-op, 2 weeks post-op, 6-8 weeks post-op and 3 months post-op
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Intra-Operative Outcomes:
Time Frame: Intra-operative
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Intra-operative data is also being collected with the intention of using it to identify any variables of the DIEP and SIEA procedures associated with the breast and abdominal outcomes being assessed in the study.
The intra-operative data being collected includes whether or not the superficial inferior epigastric vessels are present in both treatment groups.
If the vessels are present, it is recorded whether or not they are of sufficient calibre to support an SIEA flap.
This information is to show how many patients enrolled would be candidates to receive the SIEA procedure had they not been randomized to a treatment group pre-operatively.
The size of the SIEA/DIEA at the femoral artery/external iliac artery and the size of the SIEV/DIEV at the femoral vein/external iliac vein is also recorded, along with the size of the venous coupler used to anastomose the donor and recipient vein.
Other intra-op.
data is being collected as well.
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Intra-operative
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Clinical Abdominal Examination
Time Frame: 1 week post-op, 2 weeks post-op, 6-8 weeks post-op and 3 months post-op
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Patients are examined in the plastic surgery department both in the supine and upright positions for asymmetric positioning of the umbilicus, abdominal wall asymmetry, lower abdominal bulging, hernias and abdominal wound breakdown (post- operatively using calipers).
Any pre-existing scars are also noted to see if this affects complication rates.
This clinical examination is completed pre-operatively by the operating surgeon and during the regular follow-up appointments (1 week, 2 weeks, 6-8 weeks, 3 months post-op) by the head nurse, who has been instructed to do these assessments on every patient receiving DIEP or SIEA breast reconstruction.
She therefore, does not know who is actually enrolled in the study.
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1 week post-op, 2 weeks post-op, 6-8 weeks post-op and 3 months post-op
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Blair R Peters, BSc, University of Manitoba Faculty of Medicine
Publications and helpful links
General Publications
- Selber JC, Fosnot J, Nelson J, Goldstein J, Bergey M, Sonnad S, Serletti JM. A prospective study comparing the functional impact of SIEA, DIEP, and muscle-sparing free TRAM flaps on the abdominal wall: Part II. Bilateral reconstruction. Plast Reconstr Surg. 2010 Nov;126(5):1438-1453. doi: 10.1097/PRS.0b013e3181ea42ed.
- Selber JC, Nelson J, Fosnot J, Goldstein J, Bergey M, Sonnad SS, Serletti JM. A prospective study comparing the functional impact of SIEA, DIEP, and muscle-sparing free TRAM flaps on the abdominal wall: part I. unilateral reconstruction. Plast Reconstr Surg. 2010 Oct;126(4):1142-1153. doi: 10.1097/PRS.0b013e3181f02520.
- Futter CM, Webster MH, Hagen S, Mitchell SL. A retrospective comparison of abdominal muscle strength following breast reconstruction with a free TRAM or DIEP flap. Br J Plast Surg. 2000 Oct;53(7):578-83. doi: 10.1054/bjps.2000.3427.
- Blondeel N, Vanderstraeten GG, Monstrey SJ, Van Landuyt K, Tonnard P, Lysens R, Boeckx WD, Matton G. The donor site morbidity of free DIEP flaps and free TRAM flaps for breast reconstruction. Br J Plast Surg. 1997 Jul;50(5):322-30. doi: 10.1016/s0007-1226(97)90540-3.
- Bonde CT, Lund H, Fridberg M, Danneskiold-Samsoe B, Elberg JJ. Abdominal strength after breast reconstruction using a free abdominal flap. J Plast Reconstr Aesthet Surg. 2007;60(5):519-23. doi: 10.1016/j.bjps.2006.07.003. Epub 2007 Jan 17.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- B2011:120
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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