Cancer types
  • Mamma
Title of study
Patient satisfaction after oncoplastic breast reconstruction
Version Number
Approval Date 
1, 13 November 2017
Short Title
Tobo
Study site
Principle Investigator
Drs. N. Hillberg
Investigator Maastro
Dr. K. Verhoeven
Sponsor
Zuyderland MC
WHO Trial Registry
DUCG
ClinicalTrials.gov
Objectives 

The primary goal is to investigate whether there is a difference between the cosmetic outcome measured by the patient, in patients treated with and without an oncoplastic reconstruction after an intentional curative breast-conserving surgery for a breast carcinoma

Primary Endpoint 

The difference in patient satisfaction with the cosmetic result of their breast 3 months after the end of the adjuvant radiotherapy after a lumpectomy with oncoplastic breast reconstruction compared to the group of patients treated with a lumpectomy without reconstruction and adjuvant radiotherapy, using the BREAST-Q questionnaire

Secondary Endpoints 

• The difference in patient satisfaction with the cosmetic result of their breast 1 year after the end of the adjuvant radiotherapy and after an oncoplastic breast reconstruction compaired to 1 year after lumpectomy
without reconstruction and adjuvant radiotherapy, using the BREAST-Q questionnaire
• The difference in the cosmetic result directly postoperatively after an oncoplastic reconstruction with respect to the result 3 months after the adjuvant radiotherapy
• The cosmetic results of different techniques of oncoplastic breast reconstruction used
• The frequency and type of postoperative complications that occur after an oncoplastic breast reconstruction
• The frequency and type of postoperative complications that occur after a lumpectomy without reconstruction
• The effect of postoperative complications on the postponement of adjuvant radiotherapy and chemotherapy