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A Multicenter, Open, Prospective Cohort Study on the Correlation Between Different Flap Thicknesses and Postoperative Complications and Patient Outcomes in Prepectoral Implant-Based Breast Reconstruction

A Multicenter, Open, Prospective Cohort Study on the Correlation Between Different Flap Thicknesses and Postoperative Complications and Patient Outcomes in Prepectoral Implant-Based Breast Reconstruction

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400094339
Enrollment
Unknown
Registered
2024-12-20
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Breast cancer

Interventions

Flap Thickness >= 5 mm Group:None
Flap Thickness <5 mm Group:None

Sponsors

Affiliated hangzhou first people's hospital, zhejiang university school of medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Aged 18 years or older; 2.Female; 3.Preoperative pathology confirmed invasive breast cancer or ductal carcinoma in situ (DCIS); 4.Clinical T1 or T2 (maximum tumor diameter <=5 cm); 5.Clinically negative axillary lymph nodes (ALN) (clinical physical examination and ultrasound suggest negative axillary lymph nodes; patients with suspicious axillary lymph nodes must have negative fine-needle aspiration cytology results); 6.Negative sentinel lymph nodes intraoperatively; 7.No clinical or imaging evidence of distant metastasis; 8.Implant volume less than 500cc; 9.18<BMI<35; 10.Intraoperatively, the surgeon assesses the flap as having good blood supply and plans to proceed with prepectoral breast reconstruction (PBR); 11.Able and willing to sign the informed consent form;

Exclusion criteria

Exclusion criteria: 1.History of breast radiotherapy or patients requiring postoperative radiotherapy; 2.Patients requiring two-stage breast reconstruction; 3.Patients undergoing skin-sparing mastectomy (SSM); 4.Patients with significant breast ptosis requiring Wise-pattern or other breast-lifting techniques for subcutaneous mastectomy; 5.Patients receiving immediate or delayed contralateral breast symmetry surgery; 6.History of breast cancer (e.g., recurrence after breast-conserving surgery on the same side); 7.Pregnant or lactating women; 8.Patients with comorbidities such as diabetes or connective tissue diseases; 9.Long-term active smokers; 10.BMI>=35;BMI<=18; 11.Patients whose flap conditions are deemed unsuitable for PBR surgery by the surgeon;

Design outcomes

Primary

MeasureTime frame
Postoperative complications;

Secondary

MeasureTime frame
Aesthetic outcomes;Patient satisfaction;

Countries

China

Contacts

Public ContactJian Liu

Affiliated hangzhou first people's hospital, zhejiang university school of medicine

liuj1224@sina.com+86 571 56006888

Outcome results

None listed

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