Breast Cancer
Conditions
Keywords
Breast reconstruction, Early stage, Skin-saving mastectomy, Prophylactic mastectomy, Acellular dermal matrix, BRCA Mutation Carriers
Brief summary
Currently the two-stage tissue expander/implant (TE/I) technique is the standard breast reconstructive option for breast cancer patients selected for immediate, skin-sparing mastectomy. This procedure has been demonstrated to be oncologically safe in patients with specific criteria for early stage breast cancer. The primary drawback, however, is that it requires two separate procedures under general anesthesia and multiple office visits for expander inflation to create the breast mound. Acellular dermal matrix has gained widespread acceptance for use in breast reconstruction and other areas and has the potential to provide support to the breast implant without tissue expansion in a one-stage procedure. The purpose of the study is to test this new procedure and to evaluate the impact of one-stage breast reconstruction using acellular dermis compared to the standard two-stage expander/implant technique on measures of patient satisfaction and quality of life.
Detailed description
Recently, there has been significant focus on the performance of skin-sparing mastectomies in certain types of breast cancer patients. These treatments may be performed for prophylactic mastectomy but also have been demonstrated to be oncologically safe in patients with specific criteria for early stage breast cancer. Currently, the two-stage tissue expander/implant (TE/I) technique is the standard breast reconstructive option for breast cancer patients selected for immediate, skin-sparing mastectomy, however there are significant disadvantages as this technique requires two separate surgeries and multiple office visits to complete that may affect a patients quality of life. Medically safe compounds such as acellular dermal matrix have been developed that have the potential to support breast implants without requiring numerous tissue expansions and consequently providing the potential for a one-stage breast implant/reconstruction procedure for immediate, skin-sparing mastectomies. To examine patient satisfaction, quality of life and overall aesthetic outcome achieved using the acellular dermal matrix facilitated one-staged breast reconstruction at 2 weeks, 6 & 12 months following completion of the reconstruction. Hypothesis 2: Patient satisfaction, quality of life and overall aesthetic outcome achieved using the acellular dermal matrix facilitated one-stage breast reconstruction is superior to that following the standard two-stage tissue expander/ implant breast reconstruction technique in selected mastectomy patients. To determine the short and long-term operative complication rates associated with the use of dermal matrix in one-stage immediate breast reconstruction following skin-sparing mastectomy. Hypothesis 1: The use of acellular dermal matrix in one-stage immediate prosthetic breast reconstruction is associated with decreased short and long-term postoperative complications compared with the traditional two staged tissue expander/implant procedure.
Interventions
PROCEDUREOne-stage dermal matrix/implant procedure
One-stage breast reconstruction with dermal matrix and implant
PROCEDURETwo-stage tissue expander/implant procedure
Two-stage breast reconstruction with tissue expander and implant
Sponsors
Women's College Hospital
Vancouver General Hospital
Canadian Breast Cancer Foundation
Tom Baker Cancer Centre
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients who undergo immediate, implant-based reconstruction following skin-sparing and nipple-sparing mastectomy. * Patients who are older than 18 years of age and who understand English enough to complete the study questionnaires.
Exclusion criteria
* Patient refusal, patients with documented psychiatric history of psychosis or mental disorder excluding depression, patients who are active smokers. * Patients who will undergo any of the following: Autologous tissue reconstruction, patients with prior history of radiation or expected to receive post-operative radiation, patients who are pregnant, patients with grade III ptosis. * Intraoperative exclusion of those whose mastectomy flaps are deemed to be too thin or have significant ischemia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BreastQ Quality of Life and Satisfaction Questionnaire | 12 months post-op | Compare the change in the patient satisfaction and QOL scores between one-stage ADM-assisted and two-stage TE/I reconstruction without ADM over time (at 2 weeks after mastectomy, at 6 months and at 12 months following the final reconstruction procedure) from baseline scores following reconstruction using the validated BREAST-Q reconstruction module. The BREAST-Q Reconstruction Module is used to measure outcomes across four domains/sub-scales: satisfaction with the breast, psychosocial wellbeing, physical wellbeing, and sexual wellbeing. Each domain is scored on a scale of 1 to 100, with higher scores indicating better quality of life and greater patient satisfaction with more favorable outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Short Term Surgical Complications | 6- months post-op | Short complication rates were collected prospectively on intraoperative and postoperative assessment forms. Short-term complications were those that occur intraoperatively or within the first 2 months of surgery |
| Number of Participants With Long Term Surgical Complications | 12 months post-op | Long-term minor and major surgical complication rates were documented and collected prospectively on intraoperative and postoperative assessment form at 12-months follow-up visit |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| One-stage Dermal Matrix/Implant One-stage breast reconstruction with dermal matrix and implant
One-stage dermal matrix/implant procedure: One-stage breast reconstruction with dermal matrix and implant | 86 |
| Two-stage Tissue Expander/Implant Two-stage breast reconstruction with tissue expander and implant
Two-stage tissue expander/implant procedure: Two-stage breast reconstruction with tissue expander and implant | 78 |
| Total | 164 |
Baseline characteristics
| Characteristic | Two-stage Tissue Expander/Implant | Total | One-stage Dermal Matrix/Implant |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 78 Participants | 164 Participants | 86 Participants |
| Age, Continuous | 46 Years STANDARD_DEVIATION 11.2 | 45.5 Years STANDARD_DEVIATION 9.8 | 44.9 Years STANDARD_DEVIATION 8.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 27 Participants | 20 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 14 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 65 Participants | 123 Participants | 58 Participants |
| Region of Enrollment Canada | 78 participants | 164 participants | 86 participants |
| Sex: Female, Male Female | 78 Participants | 164 Participants | 86 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 86 | 0 / 78 |
| other Total, other adverse events | 7 / 86 | 6 / 78 |
| serious Total, serious adverse events | 0 / 86 | 0 / 78 |
Outcome results
Primary
BreastQ Quality of Life and Satisfaction Questionnaire
Compare the change in the patient satisfaction and QOL scores between one-stage ADM-assisted and two-stage TE/I reconstruction without ADM over time (at 2 weeks after mastectomy, at 6 months and at 12 months following the final reconstruction procedure) from baseline scores following reconstruction using the validated BREAST-Q reconstruction module. The BREAST-Q Reconstruction Module is used to measure outcomes across four domains/sub-scales: satisfaction with the breast, psychosocial wellbeing, physical wellbeing, and sexual wellbeing. Each domain is scored on a scale of 1 to 100, with higher scores indicating better quality of life and greater patient satisfaction with more favorable outcomes.
Time frame: 12 months post-op
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| One-stage Dermal Matrix/Implant | BreastQ Quality of Life and Satisfaction Questionnaire | 65.32 score on a scale | Standard Deviation 13.63 |
| Two-stage Tissue Expander/Implant | BreastQ Quality of Life and Satisfaction Questionnaire | 67.07 score on a scale | Standard Deviation 16.05 |
Comparison: For the comparison of mean BREAST-Q subdomain score at each timepoint, Mann-Whitney U test was used for skewed data, while independent t-test was used for not skewed data. We investigated the possibly variable effects of the treatment group differences across multiple time-points, namely 2 weeks after mastectomy, at 6 months and at 12 months following the reconstruction procedure. A linear regression model was used to account for the correlation between the three time-points within each patientp-value: 0.0595% CI: [-10.57, 5.19]t-test, 2 sided
Secondary
Number of Participants With Long Term Surgical Complications
Long-term minor and major surgical complication rates were documented and collected prospectively on intraoperative and postoperative assessment form at 12-months follow-up visit
Time frame: 12 months post-op
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| One-stage Dermal Matrix/Implant | Number of Participants With Long Term Surgical Complications | 23 Participants |
| Two-stage Tissue Expander/Implant | Number of Participants With Long Term Surgical Complications | 12 Participants |
Secondary
Number of Participants With Short Term Surgical Complications
Short complication rates were collected prospectively on intraoperative and postoperative assessment forms. Short-term complications were those that occur intraoperatively or within the first 2 months of surgery
Time frame: 6- months post-op
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| One-stage Dermal Matrix/Implant | Number of Participants With Short Term Surgical Complications | 32 Participants |
| Two-stage Tissue Expander/Implant | Number of Participants With Short Term Surgical Complications | 27 Participants |
Comparison: We assessed the effect of the surgical method on the occurrences of any complications versus none via logistic regression, and results were expressed as odds ratios with 95% CIs.p-value: <0.05Regression, Logistic