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A national multicenter prospective cohort study of bilateral breast endoscopic retrograde prosthesis with plus or without mesh and open graft with plus or without mesh reconstruction

A national multicenter prospective cohort study of bilateral breast endoscopic retrograde prosthesis with plus or without mesh and open graft with plus or without mesh reconstruction

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100046423
Enrollment
Unknown
Registered
2021-05-15
Start date
2021-05-15
Completion date
Unknown
Last updated
2022-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast

Interventions

Group 1:Open graft reconstruction
Group 2:Reconstruction of bilateral breast endoscopic prosthesis

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Female patients aged >=18 years; 2. Tumor diameter = 2cm; 4. There is no tumor involving the skin, nipple areola and pectoralis major; 5. There is no fusion of axillary lymph nodes, no metastasis to upper and lower clavicle lymph nodes, no metastasis to internal mammary lymph nodes; 6. Preoperative pathologically confirmed patients with bilateral breast cancer planned for surgery; 7. Preoperative pathology proved to be unilateral breast cancer, requiring symmetry plasty on the healthy side; 8. Carry BRCA1/2 gene mutation; 9. Extensive atypical hyperplasia of both breasts; 10. No distant metastasis was found before the operation; 11. The patient has a strong desire for bilateral prosthesis reconstruction, agrees to participate in this study, and is able and willing to sign an informed consent form; 12. Agree to follow up after surgery.

Exclusion criteria

Exclusion criteria: 1. A satisfactory breast shape cannot be achieved through bilateral reconstruction; 2. Patients with Paget disease of the nipple, physical examination or breast MRI suspected of nipple-areola complex involvement; 3. Inflammatory breast cancer; 4. It is found that the skin or pectoralis major muscle is involved in the tumor before or during the operation; 5. Preoperative examination found that the axillary lymph nodes were fused and fixed; 6. Merge other serious diseases.

Design outcomes

Primary

MeasureTime frame
Beauty effect;Safety;Operation time;Medical fee;Chest function;

Countries

China

Contacts

Public ContactDu Zhenggui

West China Hospital of Sichuan University

docduzg@163.com+86 13880768222

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026