Secondary outcome measures
| Outcome measure | Definition |
|---|---|
| Postoperative complications | Any postoperative complication occurring before the first adjuvant treatment or within 30 days of surgery for patients not requiring adjuvant chemotherapy or radiotherapy To be classified by the Clavien-Dindo classification of complications as applied to breast surgery46 with specific reference to: Mastectomy and breast reconstruction specific complications: seroma; haematoma; infection; mastectomy skin flap necrosis; nipple necrosis; wound dehiscence; implant loss; donor site skin necrosis; flap salvage; partial and full flap necrosis/failure Systemic complications: Deep vein thrombosis, pulmonary embolism, myocardial infarction; lower respiratory tract infection; blood transfusion; unplanned admission to high dependency or intensive therapy units; urinary tract infection |
| Readmission to hospital | Any readmission to hospital following discharge home after mastectomy ± immediate breast reconstruction surgery directly related to the procedure with either local or systemic complications in the time prior to the delivery of the first adjuvant treatment or within 30 days of surgery in those not requiring chemo or radiotherapy |
| Unplanned reoperation/return to theatre | Any unplanned re-operation or return to the operating theatre prior to the delivery of the first adjuvant therapy or in the 30 days following surgery to deal with any complication of the mastectomy or reconstruction Any planned return to theatre for additional oncological surgery, such as completion axillary clearance, as decided by the multidisciplinary team on review of surgical pathology will NOT be included in this category |
| Use of adjuvant therapy | Number (proportion) of patients undergoing mastectomy ± immediate breast reconstruction who require adjuvant Chemotherapy Biological therapy Radiotherapy |
| Omission, modification or delay of adjuvant therapy | Number (proportion) of patients undergoing mastectomy ± immediate breast reconstruction whose planned adjuvant chemotherapy/biological therapy or radiotherapy is Omitted (not given, despite MDT recommendation) Modified (dose/regimen changed from planned/standard treatment) Delayed (not given at time scheduled following oncology appointment) as a result of a postoperative complication |
| Long-term oncological outcomes | Number (proportion) of patients with and without a delay or omission of planned adjuvant chemotherapy or radiotherapy who at 5 and 10 years following their initial surgery experience Locoregional recurrence, defined as a histologically confirmed breast cancer recurrence within the ipsilateral breast or axilla Distant metastasis, defined as radiologically or histologically confirmed distant metastatic breast cancer Breast cancer specific-death, defined as death directly attributed to the disease |