A Randomized Clinical Trial Comparing 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
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.
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.
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