Background and rationale {6a}
Seroma, postoperative pain, seroma, breast cancer
BREAST CANCER, POSTOPERATIVE COMPLICATION, COMPLICATION, SEROMA, SEROMA, COMPLICATIONS
The most frequently reported complication after mastectomy and/or axillary lymph node dissection (ALND) is seroma formation. Seroma is a collection of any fluid underneath the skin flaps or in the axillary space after surgery. Seroma incidence following mastectomy is reported to be up to 90% [Seroma is a much discussed topic in literature and preventive measures are extensively reported. Fibrin glue, bovine thrombin, external compression and shoulder immobilization all seem to be ineffective or at best moderately effective [In the vast majority of hospitals mastectomy incision is closed at subcutaneous and skin level over a vacuum drain. Recent evidence, however, suggests that a postoperative drain has no value in reducing seroma formation in combination with the quilting suture technique following mastectomy [In addition to diminishing patient discomfort, quilting could decrease healthcare consumption. The omission of drains and the limited complication risk should facilitate the evolution of breast cancer surgery to day care treatment. Seroma related visits to the outpatient clinic, re-admissions and complication related to surgery are likewise expected to decrease.Despite the first report of success from quilting sutures in 1993, this technique is still not embedded in global daily practice [To date, no multicenter prospective studies have been published in which quilting without postoperative wound drain is compared with conventional wound closure with postoperative wound drain, reporting on seroma and other potential (dis)advantages.The objective of this study is therefore, to assess the impact of quilting in patients undergoing mastectomy and/or ALND in nine teaching hospitals. Postoperative complications, shoulder function, cosmetic outcome, satisfaction with thoracic wall, postoperative pain and healthcare consumption of patients treated with the quilting suture technique without drain will be compared with conventional wound closure. All these will be summarized in the primary outcome as textbook outcome. Textbook outcome is achieved if a patient suffers no wound complications, requires no re-admissions or re-operation in relation to primary surgery nor any unscheduled visit to the outpatient clinic and the postoperative use of analgesics after six months is not increased compared to pre-operative.Textbook outcome is defined as the percentage of patients for whom all desired short-term outcomes of care are realized [