Breast Cancer Stage I, Breast Cancer Stage II, In Situ Breast Cancer
Conditions
Keywords
implant-based breast reconstruction, breast cancer, PTFE mesh
Brief summary
There is currently no consensus on the gold standard for Implant-based Breast reconstruction. In the United States, more than half of all breast reconstructions are performed using acellular dermal matrix (ADM). However, based on the findings of literature and systematic reviews, it can be cautiously said that synthetic meshes cause fewer complications with comparable aesthetic results and low cost. In our study, we propose using polytetrafluoroethylene (PTFE) mesh in implant-based breast reconstruction. This material has previously proven itself in cardiovascular, maxillofacial and neurosurgery, hernioplasty and as a suture material. Allogeneic dura mater, which has demonstrated comparable results in breast reconstruction with the literature, will be used as a comparison. The purpose of this study is to evaluate the efficacy and safety of a porous, non-biodegradable, synthetic polytetrafluoroethylene mesh for implant-based breast reconstruction in patients diagnosed with breast cancer. An allogeneic dura mater technique will be used as a control. Patients eligible for this study are classified according to the National Comprehensive Cancer Network (NCCN) guidelines as having stage 0-2 breast cancer. The primary questions this study aims to answer are: * What are the rates of major and minor complications associated with these techniques. Major complications will be defined as complications leading to reoperation. * How effective are PTFE mesh and dura in maintaining the inframammary fold and implant projection after breast reconstruction? * What is the patient satisfaction rate with the surgical results? Patients will be randomly assigned to the study but will know which technique will be used in their particular case. Patients included in this study will undergo subcutaneous mastectomy or skin-sparing mastectomy using standard techniques with simultaneous implantation using PTFE mesh or allogeneic dura mater graft. In our opinion, the mesh and graft will stabilize the projections of the inframammary fold and breast implant. After the surgery, all minor and major complications will be recorded for 6 months. For this, both physical examination and radiological diagnostic methods will be used, including breast ultrasound and MRI with contrast. Revision surgeries will be performed if necessary. Projections of the inframammary fold and breast implant will also be measured in order to determine the effectiveness of the compared techniques. Patients will be asked to complete the BREAST-Q Version 2.0© Reconstruction Module questionnaire to determine satisfaction with the surgical outcome. The results of the study will help the professional community to determine the most effective method of Implant-based Breast reconstruction and will be published in peer-reviewed scientific journals.
Interventions
PROCEDUREImplant-based breast reconstruction using polytetrafluoroethylene mesh
Patients will undergo subcutaneous or skin-sparing mastectomy using the standard technique. Simultaneously, breast reconstruction will be performed using a breast implant. The lower pole of the implant and the inframammary fold will be additionally reinforced with polytetrafluoroethylene (PTFE) mesh. The lower edge of the mesh is sutured in the projection of the inframammary fold, and the upper edge is sutured to the pectoralis major muscle.
PROCEDUREImplant-based breast reconstruction using Allogeneic dura mater graft
Patients will undergo subcutaneous or skin-sparing mastectomy using the standard technique. Simultaneously, breast reconstruction will be performed using a breast implant. The lower pole of the implant and the inframammary fold will be additionally reinforced with an allogeneic dura mater graft. The lower edge of the mesh is sutured in the projection of the inframammary fold, and the upper edge is sutured to the pectoralis major muscle.
Sponsors
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
Branch Office of Hadassah Medical Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* White women; * Breast cancer stage 0-II; * Indications for breast reconstruction; * Consent to participate in the study and photographic documentation.
Exclusion criteria
* Non-white women; * Breast cancer stage III-IV; * Tubular breast; * Mental and cognitive health disorders; * Failure to comply with recommendations in the postoperative period (premature physical activity, not wearing compression underwear, missing scheduled visits, refusal of photo documentation); * Patient refusal to participate in the study at any stage.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of major and minor complications | within 6 months from the date of surgery | Major complications will be defined as complications that lead to revision surgery. These may include long-term seromas and hematomas, necrosis, infections that are not controlled by therapy or physical therapy. Also, displacement of the implant position by more than 2 cm. Minor complications will be defined as complications that do not require reoperation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of changes in projections of the implant and inframammary fold | within 6 months from the date of surgery | After the operation and after 6 months, the following distances will be measured: * from the jugular notch to the nipple; * from the middle of the clavicle to the nipple; * from the anterior midline to the nipple; * from the inframammary fold to the nipple. Calipers are used for measurements, distances are measured in the metric system. These measurements will allow you to assess the change in the position of the implant and, as a result, the shape of the breast. Changes in distances immediately after surgery and the same distances after 6 months by more than 1 cm (0.39 inches) will be considered a significant displacement of the implant. |
| Quality of life | within 6 months from the date of surgery | After surgery and 6 months later, patients will be asked to complete the BREAST-Q Version 2.0© Reconstruction Module questionnaire: * Physical well-being: chest; * Sexual well-being; * Psychosocial well-being; * Satisfaction with breast. The BREAST-Q© is a rigorously developed patient-reported outcome (PRO) measure designed to evaluate outcomes among women undergoing different types of breast surgery. In this study, the Reconstructive Module of the questionnaire will be used. There is no overall or total BREAST-Q© score, only scores for each independent scale. All BREAST-Q© scales are transformed into scores that range from 0-100. The scores are computed by adding the response items together and then converting the raw sum scale score to a score from 0-100. For all BREAST-Q© scales, a higher score means greater satisfaction or better QOL (depending on the scale). |
Countries
Russia
Contacts
Primary ContactArtem Mishin, MD
Outcome results
None listed