PARTial BREast RECONstruction With Chest Wall Perforator Flap

Cambridge University Hospitals NHS Foundation Trust1,001 enrolled

Overview

The goal of this observational study is to ascertain the outcomes following partial breast reconstruction using chest wall perforator flaps after breast conservation surgery.

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

Study Type

OBSERVATIONAL

Enrollment

1,001

Conditions

Breast Cancer Early Stage Breast Cancer (Stage 1-3)Breast Carcinoma Breast Neoplasms Breast Surgery Breast Reconstruction Surgery

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Cambridge University Hospitals NHS Trust

Cambridge, Cambridgeshire, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

Surgical Complications

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).

Time frame: Within 30 days of surgery

Secondary Outcomes

Oncological Clearance

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.

Time frame: From enrolment until the date of re-operation within 12 months of first surgery, or the end of study, whichever came first.

Revisional surgery

Outcomes: • Frequency and reasons for additional surgical procedures. Measures: • Revision rates by indication (e.g., aesthetic concerns, complication management).

Time frame: From enrolment until the date of revision within 36 months of surgery, or the end of study, whichever came first.

Oncological: Recurrence

Outcomes: • Recurrence rates (local, regional, distant). Measures: • Time to recurrence (mean/median in months).

Time frame: From enrolment until the date of recurrence, or the end of study, whichever came first, assessed up to 36 months

Oncological: Survival

Outcomes: • Survival rates Measures: • Disease-free survival (DFS) and overall survival (OS) (mean/median in months).

Time frame: From enrolment until the date of death, or the end of study, whichever came first, assessed up to 36 months

Central Contacts

Amit Agrawal, DM, FRCS

CONTACT

+44 1223 216315 amit.agrawal2@nhs.net

Data from ClinicalTrials.gov

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