Breast Reconstruction / Borstreconstructie Sensory Recovery / Herstel van Gevoel Quality of Life / Kwaliteit van Leven Microsurgical Nerve Coaptation / Microchirurgisch Zenuwherstel
Conditions
Interventions
Additional microsurgical nerve coaptation during autologous breast reconstruction with subcutaneous tissue from the abdomen (DIEP flap).
Sponsors
Maastricht University Medical Center (MUMC+)
Eligibility
Inclusion criteria
Inclusion criteria: - Female sex - 18 years or older - Diagnosed with breast cancer or carrier of BRCA1/2 gene mutations - Undergoing autologous breast reconstruction via DIEP flap (subcutaneous tissue from the abdomen) - Unilateral or bilateral breast reconstruction - Immediate or delayed breast reconstruction
Exclusion criteria
Exclusion criteria: - Postoperative radiotherapy - Known (neurological) conditions that affect the sensation such as diabetes mellitus and neruopathy (regardless of cause) - Smoking
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of the study is the difference in BREAST-Q score between the group with and the group without sensory nerve coaptation. The domains of the BREAST-Q score range from 0 to 100 points. We consider a difference between groups of 15 points as clinically meaningful. The authors of the BREAST-Q have stated that a difference between 10-20 points can be considered as a “moderate” change in QoL6, therefore the minimal difference was set at 15 points. In our recently published pilot study, a standard deviation of approximately 25 was observed4. We need to include a total of 59 patients per group to detect a difference of 15 points with a power of 80%. We expect no more than 25% of loss to follow up. As a result, we will include a total of 75 patients per group, or 150 in total. Baseline characteristics will be compared between groups: a DIEP flap breast reconstruction with sensory nerve coaptation (group 1) and a DIEP flap breast reconstruction without sensory nerve coaptation (group 2, which equals standard care). Continuous variables will be reported as mean with standard deviation or median with range, depending on the distribution of the variables. Categorical variables will be reported as absolute numbers and proportions. Continuous variables will be compared using the independent t test or the Mann–Whitney U test, and categorical variables were assessed using x2 test or Fisher’s exact test. In addition, linear rand generalized linear mixed-effects models will be used to compute an overall effect taking the longitudinal aspect of the measurements into account. | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensation of the breast: Sensation measurements of the breast(s) will be averaged in order to create one value per patient. An independent samples t test will be used to evaluate differences between both groups in mean monofilament value and mean BREAST-Q scores per domain. In addition, both simple and multiple (i.e. unadjusted and adjusted) linear regressions will be used to estimate the crude and adjusted associations between objectively measured sensation and the BREAST-Q score domains. The adjusted regression coefficient will be corrected for baseline characteristics that differed statistically significant between groups. The five additional questions will be analyzed using both simple and multiple logistic regressions and will be reported as odds ratios (OR) with a 95% confidence interval (CI). In addition, linear rand generalized linear mixed-effects models will be used to compute an overall effect taking the longitudinal aspect of the measurements into account. A p value < 0.05 was considered to be statistically significant. All analyses will be performed using IBM SPSS. | — |
Contacts
Public ContactEnnie Bijker
Maastricht Universitair Medisch Centrum
Outcome results
None listed