Breast Cancer Clinical Trial
Official title:
A Single Centre Experience of Local Perforator Flaps in Oncoplastic Breast Surgery; a Cross-sectional Study
Verified date | May 2022 |
Source | Aga Khan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is a single center experience of using local perforator flaps in partial breast reconstruction for breast tumors while evaluating cosmetic outcomes, patient satisfaction and well-being using a validated self-administered questionnaire.
Status | Completed |
Enrollment | 25 |
Est. completion date | June 30, 2021 |
Est. primary completion date | June 29, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - All female patients suitable for breast conservation who underwent a pedicled fasciocutaneous perforator flap for immediate partial breast reconstruction at the breast surgery section Exclusion Criteria: - For evaluation of surgical techniques, since this was a review of cases already operated, no cases were excluded. - For cosmetic outcomes and patient satisfaction, patients who lost to follow, expired or did not give consent to participate in the study were excluded. |
Country | Name | City | State |
---|---|---|---|
Pakistan | The Aga Khan University | Karachi | Sindh |
Lead Sponsor | Collaborator |
---|---|
Aga Khan University |
Pakistan,
BREAST-Q ® VERSION 2.0 © Memorial Sloan Kettering Cancer Center and The University of British Columbia, 2017. All rights reserved
Esser JFS. Biological- or artery flaps of the face [Internet]. Monaco: Institut Esser de Chirurgie Structive; 1931 [cited 2022 Apr 27]. Available from: https://wellcomecollection.org/works/pf3qfx2r/items?canvas=7
Fisher B, Anderson S, Redmond CK, Wolmark N, Wickerham DL, Cronin WM. Reanalysis and results after 12 years of follow-up in a randomized clinical trial comparing total mastectomy with lumpectomy with or without irradiation in the treatment of breast cancer. N Engl J Med. 1995 Nov 30;333(22):1456-61. — View Citation
Hamdi M, Van Landuyt K, de Frene B, Roche N, Blondeel P, Monstrey S. The versatility of the inter-costal artery perforator (ICAP) flaps. J Plast Reconstr Aesthet Surg. 2006;59(6):644-52. Epub 2006 Mar 22. — View Citation
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. — View Citation
Losken A, Hamdi M. Partial breast reconstruction: current perspectives. Plast Reconstr Surg. 2009 Sep;124(3):722-736. doi: 10.1097/PRS.0b013e3181b179d2. Review. — View Citation
McCulley SJ, Schaverien MV, Tan VK, Macmillan RD. Lateral thoracic artery perforator (LTAP) flap in partial breast reconstruction. J Plast Reconstr Aesthet Surg. 2015 May;68(5):686-91. doi: 10.1016/j.bjps.2015.01.008. Epub 2015 Jan 27. — View Citation
Pusic A, Klassen A, Cano S. BREAST-Q Version 2.0 © A Guide for Researchers and Clinicians [Internet]. 2017 [cited 2022 Apr 27]. Available from: https://qportfolio.org/wp-content/uploads/2018/12/BREAST-Q-USERS-GUIDE.pdf
Veronesi U, Cascinelli N, Mariani L, Greco M, Saccozzi R, Luini A, Aguilar M, Marubini E. Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. N Engl J Med. 2002 Oct 17;347(16):1227-32. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Surgical techniques of pedicled local fasciocutaneous perforator flaps in partial breast reconstruction in terms of flap anatomy | Flap anatomy involves the type of flap | May 2018 to February 2021 | |
Primary | Surgical techniques of pedicled local fasciocutaneous perforator flaps in partial breast reconstruction in terms of location of perforators | May 2018 to February 2021 | ||
Primary | Surgical techniques of pedicled local fasciocutaneous perforator flaps in partial breast reconstruction in terms of operative time | May 2018 to February 2021 | ||
Primary | Surgical techniques of pedicled local fasciocutaneous perforator flaps in partial breast reconstruction in terms of post-operative morbidities | May 2018 to February 2021 | ||
Secondary | Cosmetic outcomes of patients following local perforator flaps in oncoplastic breast conserving surgery | Cosmetic outcomes will be measured using the validated BREAST-Q Breast-Conserving Therapy (BCT) domain version 2.0. Patient's answers are converted to a number from 0 (worst) to 100 (best) using the Q-Score tool. | April 2020 to June 2021 | |
Secondary | Patient satisfaction following local perforator flaps in oncoplastic breast conserving surgery | Patient satisfaction will be measured using the validated BREAST-Q Breast-Conserving Therapy (BCT) domain version 2.0. Patient's answers are converted to a number from 0 (worst) to 100 (best) using the Q-Score tool. | April 2020 to June 2021 |
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