An observational study in Breast Tumor, Perforator Flap and Breast Cancer, sponsored by Aga Khan University. Completed at 1 site in Pakistan. Open to female participants. Per ClinicalTrials.gov, last updated 2022-05-27.
Sponsored by Aga Khan University · 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.
Background \& Objectives: Various oncoplastic techniques have emerged over the years to preserve breast cosmesis and symmetry without compromising the principles of tumor excision. One of the newer techniques for breast volume replacement to achieve symmetry and cosmesis is the use of fasciocutaneous pedicled chest wall perforator flaps or local perforator flaps (LPF). The objectives of this study are to document the details of the surgical procedure as well as patient-reported satisfaction and well-being following the already performed surgical procedure using a validated BREAST-Q tool among Pakistani women.
Materials \& Methods: This prospective cross-sectional study will be conducted by enrolling all the 25 female patients who have undergone LPF for breast tumors at The Aga Khan University Hospital, Karachi. Data related to the procedure will be collected on a pre-designed proforma. Cosmetic outcomes and patient satisfaction will be evaluated using 2 scales from BREAST-Q BCT domain version 2.0. The questionnaire will be self-administered by the patients during their routine follow-up in the clinic. Data will be analyzed using the Statistical Package for Social Sciences (SPSS) version 23. Mean (SD) / median (IQR) will be computed for quantitative variables and frequency and percentages will be calculated for qualitative variables. 2 sample t-test will be applied. P-value ≤0.05 will be considered significant.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 25 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
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All female patients who underwent a pedicled fasciocutaneous perforator flap for immediate partial breast reconstruction in the Breast section of The Aga Khan University Hospital were included in the study. For cosmetic outcomes and patient satisfaction, a follow-up of at least 3 months after surgery before participation in the survey was mandatory.
Exclusion Criteria:
This was an observational study, no intervention was done.
Surgical techniques of pedicled local fasciocutaneous perforator flaps in partial breast reconstruction in terms of flap anatomy
Flap anatomy involves the type of flap
Time frame: May 2018 to February 2021
Surgical techniques of pedicled local fasciocutaneous perforator flaps in partial breast reconstruction in terms of location of perforators
Time frame: May 2018 to February 2021
Surgical techniques of pedicled local fasciocutaneous perforator flaps in partial breast reconstruction in terms of operative time
Time frame: May 2018 to February 2021
Surgical techniques of pedicled local fasciocutaneous perforator flaps in partial breast reconstruction in terms of post-operative morbidities
Time frame: May 2018 to February 2021
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.
Time frame: April 2020 to June 2021
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.
Time frame: April 2020 to June 2021
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Plan to share: No
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Aga Khan University