Clinical trial NCT01469494: Breast and Abdominal Related Morbidity of DIEP and SIEA Flaps
Official title: A Randomized Clinical Trial Comparing Breast and Abdominal Related Morbidity of DIEP and SIEA Flaps
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: DIEP Flap Breast Reconstruction
SIEA Flap Breast Reconstruction
Keywords: DIEP flap
SIEA flap
breast reconstruction
objective isokinetic abdominal strength testing
fat necrosis
flap loss
seroma rate
abdominal wound breakdown
Breast-Q
abdominal wall outcome questionnaire
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Keeping Abreast Charity
First posted: 2011-11-10
Enrollment: 91
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Deep Inferior Epigastric Perforator flap (DIEP) is the current standard of care in breast reconstruction. The newer Superficial Inferior Epigastric Artery flap (SIEA) is felt to be an improvement as it does not damage the abdominal wall. The SIEA unfortunately has smaller vessels which put the flap at a higher risk of developing flap loss and fat necrosis. The uncertainty regarding the tradeoffs inherent in the choice of procedure has not been resolved. As such the investigators aim to perform a randomized single blinded trial to evaluate the abdominal and breast related morbidity associated with DIEP and SIEA flaps.

Detailed description: A blinded, randomized, prospective clinical trial is being performed involving Manitoban women over 18 years undergoing unilateral or bilateral breast reconstruction. Women were originally randomized 50/50 to either the DIEP or SIEA group. Due to only about 60-70% of patients randomized to the SIEA group actually receiving the SIEA procedure, the weight of the randomization has now been changed to 70/30 (SIEA/DIEP) for the remainder of the study (approx. 40/110 recruited patients waiting for their OR). Objective isokinetic abdominal strength testing is being done pre-operatively and 3, 6 and 12 months post-operatively. A self-administered validated abdominal wall and breast outcome questionnaire (Breast-Q) is also given preoperatively and at 3 and 12 months postoperatively in . Secondary outcomes measured include: fat necrosis, abdominal wound breakdown, flap loss and seroma rate. Fat necrosis is detected using ultrasonography. Abdominal wound breakdown is measured using calipers. Seroma rates are tabulated and drainage volumes measured. Statistical analyses include a combination of parametric and non-parametric tests.

Eligibility criteria: 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

Primary outcomes:
measure: Change in objective isokinetic abdominal strength
timeFrame: pre-operative (baseline), 3, 6 and 12 months post-operative
Secondary outcomes:
measure: Breast-Q questionnaire
timeFrame: pre-operative (baseline) and 3 and 12 months post-operative
measure: Fat Necrosis
timeFrame: 3 and 6 months post-operative
measure: Seroma Rate and Drainage Volumes
timeFrame: 1 week post-op, 2 weeks post-op, 6-8 weeks post-op and 3 months post-op
measure: Flap Loss
timeFrame: 1 week post-op, 2 weeks post-op, 6-8 weeks post-op and 3 months post-op
measure: Abdominal Wound Breakdown
timeFrame: 1 week post-op, 2 weeks post-op, 6-8 weeks post-op and 3 months post-op
measure: Intra-Operative Outcomes:
timeFrame: Intra-operative
measure: Clinical Abdominal Examination
timeFrame: 1 week post-op, 2 weeks post-op, 6-8 weeks post-op and 3 months post-op
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba Faculty of Medicine
name: Blair R Peters, BSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.