Breast Cancer
Conditions
Keywords
Breast Cancer, Endoscopic surgery, Minimal invasive surgery, Breast Reconstruction
Brief summary
This is a national multicenter, prospective, cohort study. The study aims to compare surgical safety (e.g., surgical complication rates), surgery-related indicators (e.g., operation time, number of operations, surgery-related costs, contralateral breast adjustment operation rates), aesthetic outcomes (e.g., BREAST-Q scores, Harris scores, SCAR-Q scores, Ueda scores and QLQ-BR45 scores), and divorce rate between patients undergoing delayed endoscopic direct-to-implant breast reconstruction via an axillary approach and those undergoing the two-stage expander-to-implant breast reconstruction following simple mastectomy.
Detailed description
Breast cancer is one of the most prevalent malignant tumors among women, with comprehensive treatment primarily centered around surgery being the mainstay approach. Mastectomy accounts for 88.8% of primary breast cancer surgeries, yet the rate of immediate breast reconstruction is only about 10.7%, resulting in the majority of patients losing their breasts at the time of initial surgery and suffering from long-term suboptimal psychosocial health, with divorce rates reaching as high as 40%. With the improvement in breast cancer treatment outcomes, an increasing number of women hope to improve postoperative breast morphology and alleviate psychological trauma through breast reconstruction. Traditional reconstruction methods include autologous tissue reconstruction and prosthetic reconstruction. The former involves significant trauma and a high incidence of complications, while the latter often requires a two-stage approach due to insufficient skin tissue, involving initial placement of a tissue expander followed by replacement with a prosthetic implant, which increases the number of surgeries and the risk of complications. To address this issue, our team has developed a novel delayed endoscopic direct-to-implant breast reconstruction technique via an axillary incision approach with insufflation, which requires only a single surgery, significantly reducing surgical time, trauma, and costs, as well as the incidence of complications. Postoperatively, there are no fresh incisions on the breast, resulting in a more natural appearance and softer feel. This study aims to compare this technique with the traditional two-stage approach, exploring postoperative complications, aesthetic outcomes, quality of life, cost-effectiveness, and surgical-related indicators. To comprehensively evaluate its clinical benefits, large-scale multicenter studies are required to provide evidence-based medical evidence and optimize surgical strategies. Therefore, this national multicenter, prospective, cohort study will compare surgical safety (e.g., surgical complication rates), surgery-related indicators (e.g., operation time, number of operations, surgery-related costs, contralateral breast adjustment operation rates), aesthetic outcomes (e.g., BREAST-Q scores, Harris scores, SCAR-Q scores, Ueda scores and QLQ-BR45 scores), and divorce rate between patients undergoing delayed endoscopic direct-to-implant breast reconstruction via an axillary approach and those undergoing the two-stage expander-to-implant breast reconstruction following simple mastectomy.
Interventions
PROCEDUREDelayed endoscopic direct-to-implant breast reconstruction
This technique allows for breast reconstruction in a single operation. Taking dual-plane breast reconstruction as an example, preoperative marking lines are drawn to indicate the contour and inframammary fold of the reconstructed breast. A 4-5 cm axillary incision is placed one finger-breadth below the axillary apex. After making the skin incision, the plane between the pectoralis major and minor muscles is identified and dissected, extending approximately 2 cm below the previous mastectomy horizontal scar. The inner and lower parts of the pectoralis major muscle were then separated. Proceed to the subcutaneous layer and continue to dissociate the flap until it reaches the pre-designed folds and the breast boundary. The use of the TiLOOP® Bra depends on the thickness of the patient's flap. Finally, the prosthesis is placed behind the pectoralis major muscle for breast reconstruction.
PROCEDURETwo-stage expander-to-implant breast reconstruction
The two-stage expander-to-implant breast reconstruction involves initially placing a tissue expander to stretch the skin. Once the skin has sufficient capacity, a second surgery is performed to replace the expander with a breast implant. The expander can be gradually adjusted based on the patient's skin expansion progress, physical recovery, and aesthetic needs to achieve optimal reconstruction results.
Sponsors
West China Hospital
West China Second University Hospital
Fourth People's Hospital of Sichuan Province
West China Fourth Hospital
The Second People's Hospital of Chengdu
Suzhou Municipal Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Female patients aged 18-70 years (inclusive) who have undergone simple mastectomy for breast cancer; * At least 1 year after simple mastectomy or 6 months after completion of radiotherapy, with good local skin viability and skin laxity; * Voluntary provision of informed consent.
Exclusion criteria
* Local/regional recurrence or uncontrolled distant metastasis detected upon re-examination (clinical, imaging, or pathological evidence); * Pectoralis major muscle was resected during the initial surgery; * Preoperative severe comorbidities with poor general condition, rendering the patient unable to tolerate surgery; * Immunodeficiency; * Long-term smoking history or poorly controlled diabetes mellitus; * Currently participating in other clinical trials that may affect the results of this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical complication rates | Postoperative 2 years | Surgical complication rates, major complication rates and minor complication rates, including flap scald, NAC ischemia/necrosis, seroma, surgical area infection, bleeding, incision splitting, flap ischemia/necrosis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operation time | Intraoperative | The surgical time includes total anesthesia time, total operative time, and flap dissociation time. |
| Number of operations | Intraoperative | The number of surgical procedures performed, representing the total count of operations conducted. |
| Contralateral breast adjustment operation rates | Intraoperative | The rate of contralateral breast adjustment operations, defined as the proportion of patients who undergo additional surgical procedures to modify or adjust the contralateral (opposite) breast to achieve symmetry with the reconstructed breast. |
| Surgery-related costs | Postoperative 1 month | Surgery-related costs include total hospitalization expenses, surgical costs, postoperative dressing change costs, expander injection costs, etc. |
| Aesthetic outcomes (BREAST-Q score) | Postoperative 6 months and 2 years | The BREAST-Q scores range from 0 to 100, with higher scores indicating better outcomes. Both raw questionnaire scores and standardized transformed scores will be documented, along with pre- to postoperative differences in transformed scores. |
| Aesthetic outcome (SCAR-Q score) | Postoperative 6 months and 2 years | A validated scar-specific patient-reported outcome measure tool for assessing the quality of life of patients with scars. It consists of three independent scales: scar appearance, scar symptoms, and psychosocial impact. Transformed scores range from 0 to 100, with higher scores indicating better outcomes. |
| Aesthetic outcome (Harris score) | Postoperative 6 months and 2 years | The Harris score was used to record the subjective judgment of symmetry of the reconstructed breast compared to the contralateral breast. The results were categorized as excellent (treated breast nearly identical to untreated breast), good (treated breast slightly different than untreated), fair (treated breast clearly different than untreated), and poor (treated breast seriously distorted). |
| Aesthetic outcome (Ueda score) | Postoperative 6 months and 2 years | Doctor-reported aesthetic outcomes will be evaluated by three professional breast surgeons using the Ueda scale, based on postoperative photographs. Scores range from 0 to 10 points, with higher values indicating better results. The categorized as follows: Excellent (≥9 points), Good (7-8 points), Fair (5-6 points), Poor (≤4 points). Both raw scores and categorizations will be documented. |
| Quality of Life (EORTC Quality of Life scores) | Postoperative 6 months and 2 years | EORTC Scores are a series of questionnaires developed by the European Organisation for Research and Treatment of Cancer (EORTC) to assess the health-related quality of life (HRQoL) of cancer patients. These questionnaires are widely used in clinical trials and clinical practice to help evaluate treatment outcomes and patients' quality of life. The scoring range is from 0 to 100. A higher score in the functional domains indicates better functioning, while a higher score in the symptom domains indicates more severe symptoms. |
| Implant-assisted complications | Postoperative 6 months and 2 years | Implant-assisted complication rates, including rippling, prosthesis outline appearance, capsular contraction, prosthesis rotation. |
| Divorce rates | Postoperative 6 months and 2 years | Divorce rates |
Countries
China
Contacts
CONTACTZhenggui Du
Outcome results
None listed