Secondary study parameters/endpoints
necrosis, bleeding, malignancy, SSI, seroma, seromas, hematoma, in recurrent breast cancer
NECROSIS, ANGIOSARCOMA, BLEEDING, SURGICAL COMPLICATIONS, SITE INFECTION, WOUND DEHISCENCE, SEROMA, SEROMAS, HEMATOMA, COMPLICATIONS
Wound complications are defined by the Clavien Dindo classification of Surgical Complications [All palpation-detected seromas (non-aspirated), proportion (%)Clinical significant seroma (aspirated seroma), proportion (%)Surgical site infections (SSI), proportion (%)Wound hematoma or bleeding, skin flap necrosis, wound dehiscence, visualized by inspection, proportion (%)Health care consumption:Duration of surgery: time from incision till wound closed (minutes), meanDuration of hospital stay (treatment in day care or amount of nights, day care classified 0), meanNumbers of unscheduled visits to the outpatients clinic (one postoperative visit is scheduled), medianReadmission to the hospital related to primary surgery, medianReoperation, related to primary surgery other than re-excision, medianBaseline characteristics based on assumed risk factors for formation of seroma [Biological gender, proportion (%)Age (years at day of surgery), meanBMI (kg/mWeight of the removed breast (gram), meanPolypharmacy (use of five or more medications daily [TNM classification (type 1 to 4, no malignancy, in situ, ypT0N0, angiosarcoma), nominal, proportion per stage (%)Type of surgery (uni- or bilateral mastectomy, ALND or a combination), nominal, proportion per type (%)Prior irradiation of the breast in recurrent breast cancer, proportion (%)Neoadjuvant chemotherapy, proportion (%)Other:Shoulder function questionnaire (DASH questionnaire = Disability of the Arm, Shoulder and Hand [Post-operative pain (visual analogue scale day 1–14 postoperative and use of analgesics), median scoreCosmetic outcome (an independent panel of four surgeons will blindly assess cosmetics by classifying standardised digital photographs one a 4-point Likert scale with the following categories: poor, fair, good and excellent. Photos are taken in two positions: the first in neutral position with both arms hanging next to the body and the second with both arms raised in 180gr (or as far as possible) elevation).Satisfaction with thoracic wall (BreastQ questionnaire for mastectomy [