Physician Diana Lydia Dyrberg Department of Plastic Surgery, Odense University Hospital
Projektet i tal
OPEN undersøgelse/kliniske data
Forventet # af deltagere
Inkluderet antal deltagere
Inkluderede deltagere med prøver
Direct to implant extracellular matrix hammock based pre- or retropectoral breast reconstruction
Different techniques for immediate breast reconstruction following mastectomy have been introduced. Prepectoral/subglandular implant placement using a full extracellular hammock has shown to entail benefits regarding a lesser degree of involuntary deformation of the implant when activating the m. pectoralis major (breast animation deformity) compared to the standard method of retropectoral/submuscular placement of the implant.
Women eligible for immediate breast reconstruction will be invited to participate in this randomized controlled trial where subglandular and submuscular placement of the implant will be compared. Between groups we will assess the degree of breast animation deformity; quality of life; postoperative pain; postoperative complications; shoulder and arm function; surgical corrections; length of stay; capsular contraction; aesthetic outcome and temperature evaluation.
Description of the cohort
Women over 18 years referred to the Department of plastic surgery, Odense University Hospital, Lillebaelt Hospital, Vejle, Denmark or Telemark Hospital, Skien, Norway between April 2017 and July 2018, who are found eligible for immediate breast reconstruction using the retropectoral implant placement are invited to participate in the study.
Data and biological material
Before surgery all relevant data will be collected in the outpatient clinic. This includes an interview, photo and video recordings of the breast with and without movement of the pectoralis major muscle, clinical examination including shoulder and arm function, photography and the completion of a Breast-Q questionnaire.
Patients are closely monitored after surgery as all relevant data are collected, and the different end-points are evaluated at 3 and 12 month in the outpatient clinic after they are discharged from the hospital.
Collaborating researchers and departments
Department of Plastic Surgery, Odense University Hospital