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| Name | Class |
|---|---|
| Oxford University Hospitals NHS Trust | OTHER |
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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
B) Treatment characteristics
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | Within 30 days of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrolment until the date of re-operation within 12 months of first surgery, or the end of study, whichever came first. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Pre-operative, Post-operative and Post-radiotherapy (6 months). |
Inclusion Criteria:
Exclusion Criteria:
Female breast cancers
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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)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amit Agrawal, DM, FRCS | Contact | +44 1223 216315 | amit.agrawal2@nhs.net |
| Name | Affiliation | Role |
|---|---|---|
| Amit Agrawal | Cambridge University Hospitals NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cambridge University Hospitals NHS Trust | Recruiting | Cambridge | Cambridgeshire | CB2 0QQ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37544090 | Background | Agrawal A, Romics L, Thekkinkattil D, Soliman M, Kaushik M, Barmpounakis P, Mortimer C, Courtney CA, Goyal A, Garreffa E, Carmichael A, Lane RA, Rutherford C, Kim B, Achuthan R, Pitsinis V, Goh S, Ray B, Grover K, Vidya R, Murphy J; PartBreCon Collaborators. 'PartBreCon' study. A UK multicentre retrospective cohort study to assess outcomes following PARTial BREast reCONstruction with chest wall perforator flaps. Breast. 2023 Oct;71:82-88. doi: 10.1016/j.breast.2023.07.007. Epub 2023 Jul 17. | |
| 37061072 |
| Label | URL |
|---|---|
| Lead Site | View source |
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Since it is a large international observational study, any sharing will need approval from all though anonymised data might be shareable (to be decided later).
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 31, 2023 | Nov 26, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Revisional surgery | Outcomes: • Frequency and reasons for additional surgical procedures. Measures: • Revision rates by indication (e.g., aesthetic concerns, complication management). | 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). | 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). | From enrolment until the date of death, or the end of study, whichever came first, assessed up to 36 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. | Pre-operative, Post-operative and Post-radiotherapy (6 months). |
| Background |
| Garreffa E, Meattini I, Coles CE, Agrawal A. Use of tumour bed boost radiotherapy in volume replacement oncoplastic breast surgery: A systematic review. Crit Rev Oncol Hematol. 2023 Jun;186:103996. doi: 10.1016/j.critrevonc.2023.103996. Epub 2023 Apr 14. |
| 30710399 | Background | Agrawal A. Oncoplastic breast surgery and radiotherapy-Adverse aesthetic outcomes, proposed classification of aesthetic components, and causality attribution. Breast J. 2019 Mar;25(2):207-218. doi: 10.1111/tbj.13193. Epub 2019 Feb 1. |
| Background | Association of Breast Surgery A. NHSBSP and ABS Audit. Accessed 24.05.2020, https://associationofbreastsurgery.org.uk/professionals/audit/nhs-breast-screening-programme-audit/ |
| 32284305 | Background | Garreffa E, Hughes-Davies L, Russell S, Lightowlers S, Agrawal A. Definition of Tumor Bed Boost in Oncoplastic Breast Surgery: An Understanding and Approach. Clin Breast Cancer. 2020 Aug;20(4):e510-e515. doi: 10.1016/j.clbc.2020.03.003. Epub 2020 Mar 20. |
| Background | Agrawal A, Mirshekar-Syahkal B. Use of combination of modules of BREAST-Q in partial breast reconstruction with lateral chest wall perforator flap. Eur J Surg Oncol. 2016;42(5):S39. doi:https://doi.org/10.1016/j.ejso.2016.02.155 |
| 17180559 | Background | Navin C, Agrawal A, Kolar KM. The use of latissimus dorsi miniflap for reconstruction following breast-conserving surgery: experience of a small breast unit in a district hospital. World J Surg. 2007 Jan;31(1):46-50. doi: 10.1007/s00268-006-0396-7. |
| 15308400 | Background | Hamdi M, Van Landuyt K, Monstrey S, Blondeel P. Pedicled perforator flaps in breast reconstruction: a new concept. Br J Plast Surg. 2004 Sep;57(6):531-9. doi: 10.1016/j.bjps.2004.04.015. |
| 28861373 | Background | Roy PG, Tenovici AA. Staged approach to partial breast reconstruction to avoid mastectomy in women with breast cancer. Gland Surg. 2017 Aug;6(4):336-342. doi: 10.21037/gs.2017.03.08. |
| 29980320 | Background | Brouwers PJAM, van Werkhoven E, Bartelink H, Fourquet A, Lemanski C, van Loon J, Maduro JH, Russell NS, Scheijmans LJEE, Schinagl DAX, Westenberg AH, Poortmans P, Boersma LJ; Young Boost Trial research group. Predictors for poor cosmetic outcome in patients with early stage breast cancer treated with breast conserving therapy: Results of the Young boost trial. Radiother Oncol. 2018 Sep;128(3):434-441. doi: 10.1016/j.radonc.2018.06.020. Epub 2018 Jul 3. |
| D017437 |
| Skin and Connective Tissue Diseases |