Health Condition 1: C50- Malignant neoplasm of breast
Conditions
Interventions
Intervention1: NIL: No intervention agents as this is an observational study.
Control Intervention1: Nil: No comparator agent as this is an observational study.
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients undergoing partial breast reconstruction using CWPF for primary breast cancer 2. Delayed correction of breast deformity following previous BCS 3. Each surgeon is to have performed a minimum of 10 CWPFs 4. Each centre anticipates completing a minimum of 10/year
Exclusion criteria
Exclusion criteria: 1. Patients undergoing volume displacement BCS 2. Patients undergoing mastectomy +/- immediate breast reconstruction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A) Patient Demographics and Tumour characteristics 1. Patient demographics: age, body mass index (BMI), comorbidities 2. Preoperative tumour characteristics and location influencing surgical planning B) Treatment characteristics 1. Surgical: operative data, including flap types and distribution 2. Oncological: systemic therapies (adjuvant and neoadjuvant), radiotherapy C) Primary outcome: Surgical 1. Complications 2. Oncological clearance: Re-excision rates, conversion to mastectomy D) Secondary outcomes 1. Revisional surgery 2. Surveillance 3. Oncological: Recurrence and Mortality E) Patient-reported outcomes 1. Pre-operative 2. Post-operative (pre-radiotherapy) 3. Post-radiotherapy (6 months)Timepoint: A) Patient Demographics and Tumour characteristics 1. Patient demographics: age, body mass index (BMI), comorbidities 2. Preoperative tumour characteristics and location influencing surgical planning B) Treatment characteristics 1. Surgical: operative data, including flap types and distribution 2. Oncological: systemic therapies (adjuvant and neoadjuvant), radiotherapy C) Primary outcome: Surgical 1. Complications 2. Oncological clearance: Re-excision rates, conversion to mastectomy D) Secondary outcomes 1. Revisional surgery 2. Surveillance 3. Oncological: Recurrence and Mortality E) Patient-reported outcomes 1. Pre-operative 2. Post-operative (pre-radiotherapy) 3. Post-radiotherapy (6 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Revisional surgery 2. Surveillance 3. Oncological: Recurrence and MortalityTimepoint: 30 days after surgery 3 monthly after treatment completion for the first two years, 6 monthly for the next 3 years, Yearly thereafter (after 5th year) | — |
Countries
Australia, France, Germany, India, Italy, United Kingdom
Contacts
Public ContactJyoutishman Saikia
NCI AIIMS New Delhi
Outcome results
None listed