Breast cancer
Conditions
Interventions
Experimental Group:Endoscopic latissimus dorsi breast reconstruction surgery Robotic latissimus dorsi breast reconstruction surgery
Control group:Open latissimus dorsi muscle transfer for breast reconstruction surgery
Sponsors
First Affiliated Hospital of Army Medical University of the Chinese People's Liberation Army
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Female patients aged >= 18 years and = 20% of the breast volume, and clinical judgment indicates that latissimus dorsi muscle flap transfer reconstruction is required to improve the appearance; (2) No severe shoulder diseases (such as periarthritis of the shoulder, rotator cuff injury, etc.), and can cooperate with shoulder function rehabilitation training after surgery to avoid aggravation of donor site dysfunction; (3) No surgical history, infection history or skin diseases (such as severe scars, eczema, etc.) in the back donor site, to ensure the feasibility of obtaining the latissimus dorsi muscle flap; 2. Histologically confirmed invasive breast cancer; 3. No previous axillary surgery history or preoperative examination indicating that the thoracodorsal vessels are intact; 4. ECOG PS score: 0-1; 5. Major organ function is good and meets the following criteria: (1) Blood routine test criteria (no blood transfusion or hematopoietic stimulating factor drugs within 7 days before screening; drug correction) : 1) hemoglobin (HGB) >=90g/L; 2) absolute neutrophil count (NEUT) >=1.5×10^9/L; 3) platelet count (PLT) >=100×10^9/L; 4) white blood cell >=2.5×10^9/L. (2) Biochemical tests should meet the following criteria: 1) Total bilirubin (TBIL) =50ml/min (Cr clearance was calculated according to Cockroft-Gault formula). (3) Coagulation function tests should meet the following criteria: 1) Prothrombin time (PT), activated partial thromboplastin time (APTT), and international normalized ratio (INR) =55%; 2) 12-lead ECG: QT interval, female < 470ms. 6. Voluntarily participate in this study, sign the informed consent form, have good compliance and are willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1.Those with a history of thoracic and dorsal vascular injury; 2. Those with a history of radiotherapy; 3. The pathological type is a special type of breast cancer (such as inflammatory breast cancer, breast Paget's disease); 4. Having received anti-tumor treatment or radiotherapy for any malignant tumor within the past five years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin or squamous cell carcinoma; 5. There are uncontrollable comorbidities (such as severe heart failure, acute exacerbation of chronic obstructive pulmonary disease, active infection, etc.), making it impossible to tolerate surgery; 6. There is breast cancer metastasis; 7. Bilateral breast cancer; 8. Simultaneously participate in clinical trials of other anti-tumor therapies (including endocrine therapy or immunotherapy, etc.); 9. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA >=500 IU/ml), hepatitis C (positive hepatitis C antibody and HCV-RNA higher than the detection limit of the analytical method), or co-infection with hepatitis B and hepatitis C; 10. There is a known history of abuse or drug use of psychotropic substances; 11. In the lactation or pregnancy period; 12. Any other circumstances in which the researcher deems the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient satisfaction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgery-related indicators;Postoperative recovery indicators;Incidence rate of complications; | — |
Countries
China
Contacts
Public ContactZhang Yi
The First Affiliated Hospital of Army Medical University of the People's Liberation Army of China
Outcome results
None listed