OPEN Research Support

Camilla Bille
Department of Plastic Surgery, Odense University Hospital

Projekt styring
Projekt status    Sampling ongoing
Data indsamlingsdatoer
Start 01.01.2018  
Slut 15.08.2018  

Analysis of surgical complications in women treated with either mastectomy or mastectomy and immediate breast reconstruction with silicone implants.

Short summary

For a lot of female breast cancer patients, it is traumatizing to undergo a mastectomy and loose one or both breasts. Immediate breast reconstruction (IBR) can provide a positive psychological effect, and help women return to daily life. However, questions have been raised as whether the extended surgery IBR oftener results in   in severe complications. Such severe complications might have an impact on the time to upstart in adjuvant life preserving chemotherapy or radiation therapy.



Each year nearly 20.000 females will be diagnosed with breast cancer in the Nordic countries. It is the most common cancer type for females in Denmark. In 2016 over 3500 women in Denmark had a mastectomy. The surgical treatment is depended on the cancer size, breast size and desire of the patient. Most women with breast cancer will receive adjuvant therapy in form of chemotherapy, hormone suppressive and/or radiation treatment.


The surgical treatment consists of one of two options, the breast-conserving operation, lumpectomy and the non-breast-conserving operation, mastectomy where all breast tissue is removed. Women who undergo mastectomy will be offered immediate reconstruction if this is possible.


Most breast cancer patients require adjuvant therapy after the surgery. This makes it even more important to reduce complications from the surgical procedure since complication like infection, necrosis or wound dehiscence can postpone adjuvant therapy. There are concerns that IBR have a higher complication-rate because of the extended surgery and implant pressing on the skin flaps.


The risk of potential complications and their effect on time to delivery of adjuvant therapy must be taken into account for each woman and counterbalanced by the advantages of an immediate breast reconstruction.


The different complications can be divided into minor and major, depending on whether they need surgical treatment (and explantation of the implant) or can be handled conservatively. Complications are depending of several factors including patient-characteristics like BMI, size of the removed breast, smoking, hypertension, previously radiation-treatment, diabetes, and other comorbidities. Surgically, the aspects of traumatizing the tissue, lack of sterile conditions, surgical techniques and implant size also play a part in the combined risk assessment.


Description of the cohort

After receiving approval from the Danish Data Protection Agency and Danish Patient Safety Authority, a search was made for all patients who received a procedure with one of the following DRG-codes: Khac10/15/20/25 within the period from the 1st of January 2014 to 1st of July 2017 at Odense University Hospital. To be included in this study, the patients must be female and been diagnosed with either DCIS or breast cancer. Women were excluded if the procedures was done prophylactic or was diagnosed with a different active malignant cancer that required chemotherapy.


Data and biological material

Demographic, surgical, pathological and treatment related to the surgery including neoadjuvant and adjuvant therapy on the study population is collected from their medical journals. There will be no contact with the patients in the study, and no biological material will be needed to complete this study. 


Collaborating researchers and departments

Department of Plastic Surgery, Odense University Hospital, Denmark.

  • Consultant Camilla Bille, PhD, MD.
  • Consultant Jørn Bo Thomsen, PhD, MD.
  • Emma Thyra Lund,
  • Department of Oncology, Odense University Hospital, Denmark.
  • Consultant Søren Cold, MD.