A Study on Surgical and Patient-Reported Outcomes After Breast-Conserving Surgery with Chest Wall Flap Reconstruction in Breast Cancer Patients
Not yet recruiting
- Conditions
- Malignant neoplasm of breast,
- Registration Number
- CTRI/2025/05/087008
- Lead Sponsor
- Not applicable
- Brief Summary
Summary of PartBreCon-Pro Study Protocol
- Study Type: Multicentre prospective cohort study on partial breast reconstruction using chest wall perforator flaps (CWPF).
- Objective: Evaluate clinical and patient-reported outcomes post-breast-conserving surgery.
- Duration: 36 months (June 2023 - May 2026).
- Data Collection: Includes surgical outcomes, oncological treatment, and patient-reported outcomes (PROMs).
- Significance: Aims to establish performance standards and improve patient care in breast cancer treatment.
- Contact: partbrecon.pros@gmail.com
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 1000
Inclusion Criteria
- 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
- Patients undergoing volume displacement BCS 2.
- Patients undergoing mastectomy +/- immediate breast reconstruction.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2. Preoperative tumour characteristics and location influencing surgical planning 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) B) Treatment characteristics 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) 1. Patient demographics: age, body mass index (BMI), comorbidities 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) 3. Post-radiotherapy (6 months) 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) A) Patient Demographics and Tumour characteristics 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) 1. Surgical: operative data, including flap types and distribution 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) 2. Oncological: systemic therapies (adjuvant and neoadjuvant), radiotherapy 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) 2. Surveillance 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) 3. Oncological: Recurrence and Mortality 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) E) Patient-reported outcomes 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) 1. Pre-operative 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) 2. Post-operative (pre-radiotherapy) 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) C) Primary outcome: Surgical 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) 2. Oncological clearance: Re-excision rates, conversion to mastectomy 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) D) Secondary outcomes 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) 1. Revisional surgery 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) 1. Complications 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 Outcome Measures
Name Time Method 1. Revisional surgery 2. Surveillance
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the long-term oncological outcomes of chest wall perforator flap reconstruction in breast cancer patients undergoing breast-conserving surgery?
How do patient-reported outcomes from CTRI/2025/05/087008 compare with traditional autologous reconstruction methods in breast cancer treatment?
What biomarkers correlate with improved aesthetic and functional results in partial breast reconstruction using CWPF techniques?
Are there specific adverse events associated with chest wall perforator flap surgery that require tailored management strategies in breast cancer care?
How does the use of chest wall perforator flaps in partial breast reconstruction influence recurrence rates and quality of life compared to mastectomy with reconstruction?
Trial Locations
- Locations (1)
AIIMS New Delhi
🇮🇳South, DELHI, India
AIIMS New Delhi🇮🇳South, DELHI, IndiaDr Jyoutishman SaikiaPrincipal investigator9612892050jyoutishman@gmail.com