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For patients refusing implants for breast reconstruction after cancer surgery, autologous tissue flap reconstruction using the latissimus dorsi muscle is an alternative. Conventional surgery leaves a long incision on the back, affecting aesthetics and quality of life. Minimal access techniques result in a smaller, more concealable scar. While previous studies suggest its safety and effectiveness, most are retrospective. To further validate patient satisfaction and short-term outcomes, a prospective, randomized controlled trial comparing minimal access with conventional surgery is planned. The primary endpoint is Breast Q-satisfaction with back score at 6 months. Secondary outcomes include other Breast Q subscales, surgical metrics, and complications. The study aims to enroll 94 patients in total, providing evidence for surgical decision-making in breast cancer reconstruction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| minimal access group | Experimental |
| |
| conventional group | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| minimal access breast reconstruction with a latissimus dorsi muscle flap | Device | minimal access breast reconstruction with a latissimus dorsi muscle flap |
|
| Measure | Description | Time Frame |
|---|---|---|
| Breast Q-satisfaction with back | Patient satisfaction with the back, assessed using the Breast Q-satisfaction with back subscale. 6 months after surgery, the doctor provided each patient with a Breast Q-satisfaction with back questionnaire, and asked the patient to fill in the questionnaire truthfully, and each questionnaire took 1-4 minutes to complete. Before each questionnaire is completed, the doctor will give the patient a simple guide to make it clear what each option means. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction | Other aspects of patient satisfaction, assessed using the Breast Q scale. 6 months after surgery, the doctor provided each patient with a questionnaire and asked the patient to fill it out truthfully, each questionnaire takes 1-4 minutes to complete, and a complete BREAST-Q survey can be completed in 10-15 minutes. Before each questionnaire is completed, the doctor will give the patient a simple guide to make it clear what each option means. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shicheng Su | Contact | +8613631304227 | sushch@mail.sysu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510120 | China |
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| conventional breast reconstruction with a latissimus dorsi muscle flap | Device | conventional breast reconstruction with a latissimus dorsi muscle flap |
|
| 6 months |
| Latissimus dorsi acquisition time | Calculated from the start of latissimus dorsi acquisition to the completion of latissimus dorsi acquisition. | Perioperative |
| Intraoperative blood loss | The amount of blood lost by the patient due to routine operations during surgery. | Perioperative |
| Postoperative pain | recorded using the Visual Analogue Scale (VAS) pain assessment tool. | Perioperative |
| Postoperative complications | including but not limited to surgical site infection, bleeding, wound dehiscence, breast/donor site flap/NAC necrosis, subcutaneous effusion in the chest and donor site, surgical side lymphedema, etc., are classified using the Clavien-Dindo grading system. | 6 months |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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