Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Carcinoma, Breast Neoplasms, Breast Reconstruction Surgery, Breast Surgery
Conditions
Keywords
breast oncoplastic, recon, chest wall perforator flap, PROMS
Brief summary
The goal of this observational study is to ascertain the outcomes following partial breast reconstruction using chest wall perforator flaps after breast conservation surgery.
Detailed description
The Main Outcomes and Measures are: 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
Interventions
None listed
Sponsors
Oxford University Hospitals NHS Trust
Cambridge University Hospitals NHS Foundation Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing partial breast reconstruction using CWPF for primary breast cancer * Delayed correction of breast deformity following previous BCS * Each surgeon is to have performed a minimum of 10 CWPFs * Each centre anticipates completing a minimum of 10/year
Exclusion criteria
* Patients undergoing volume displacement BCS * Patients undergoing mastectomy +/- immediate breast reconstruction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Complications | Within 30 days of surgery | Outcomes: • Rates of complications (e.g., Haematoma, Seroma, Infection, Delayed Wound healing, Fat necrosis, Flap loss, etc). Measures: • Complication rates stratified by severity (e.g., Clavien-Dindo classification). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oncological Clearance | From enrolment until the date of re-operation within 12 months of first surgery, or the end of study, whichever came first. | Outcomes: • Effectiveness of surgery in achieving oncological goals. Measures: • Re-operation rates: Proportion of patients requiring further surgery (re-excisions and/or mastectomy) to achieve Oncological clearance. |
| Revisional surgery | From enrolment until the date of revision within 36 months of surgery, or the end of study, whichever came first. | Outcomes: • Frequency and reasons for additional surgical procedures. Measures: • Revision rates by indication (e.g., aesthetic concerns, complication management). |
| Oncological: Recurrence | From enrolment until the date of recurrence, or the end of study, whichever came first, assessed up to 36 months | Outcomes: • Recurrence rates (local, regional, distant). Measures: • Time to recurrence (mean/median in months). |
| Oncological: Survival | From enrolment until the date of death, or the end of study, whichever came first, assessed up to 36 months | Outcomes: • Survival rates Measures: • Disease-free survival (DFS) and overall survival (OS) (mean/median in months). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported outcomes: Patient satisfaction and quality of life | Pre-operative, Post-operative and Post-radiotherapy (6 months). | Outcomes: • Patient satisfaction and quality of life (QoL). Measures: • Measurement using a validated instrument, BREAST-Q, which converts the individual patient response items into a BREAST-Q score ranging from 0-100; a higher score means greater satisfaction of better QoL |
| Patient-reported outcomes: Upper extremity dysfunction | Pre-operative, Post-operative and Post-radiotherapy (6 months). | Outcomes: • Disability of the Arm, Shoulder and Hand Measures: • Measurement using a validated instrument, QuickDASH (an abbreviated version of the Disability of the Arm, Shoulder, and Hand), which converts the individual patient response items into a QuickDASH score ranging from 0 to 100; a higher score means a greater level of disability and severity. |
Countries
United Kingdom
Contacts
Primary ContactAmit Agrawal, DM, FRCS
Outcome results
None listed