PARTial BREast RECONstruction With Chest Wall Perforator Flap

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

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age18+

SponsorCambridge University Hospitals NHS Foundation Trust

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients undergoing volume displacement BCS

Patients undergoing mastectomy +/- immediate breast reconstruction

Trial population

Women over the age of 18 years who would have been offered all options (simple wide local excision, therapeutic mammaplasty, mastectomy with or without immediate whole breast reconstruction)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial 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

Other outcomes

Patient-reported outcomes: Patient satisfaction and quality of life

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

Time frame

Pre-operative, Post-operative and Post-radiotherapy (6 months).

Patient-reported outcomes: Upper extremity dysfunction

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.

Time frame

Pre-operative, Post-operative and Post-radiotherapy (6 months).

Sponsors and contacts

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Cambridge University Hospitals NHS Foundation Trust

Lead sponsor

Oxford University Hospitals NHS Trust

Collaborator

Source ClinicalTrials.gov

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