Clinical trial NCT05389605: Outcomes of Local Perforator Flaps in Oncoplastic Surgery
Official title: A Single Centre Experience of Local Perforator Flaps in Oncoplastic Breast Surgery; a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Tumor
Perforator Flap
Breast Cancer
Oncoplasty
Breast-Q
Keywords: Local Perforator Flaps
Breast Cancer
Oncoplastic Breast Conserving Surgery
BREAST-Q
Breast Surgery
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 25
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Surgical techniques of pedicled local fasciocutaneous perforator flaps in partial breast reconstruction in terms of flap anatomy
timeFrame: May 2018 to February 2021
measure: Surgical techniques of pedicled local fasciocutaneous perforator flaps in partial breast reconstruction in terms of location of perforators
timeFrame: May 2018 to February 2021
measure: Surgical techniques of pedicled local fasciocutaneous perforator flaps in partial breast reconstruction in terms of operative time
timeFrame: May 2018 to February 2021
measure: Surgical techniques of pedicled local fasciocutaneous perforator flaps in partial breast reconstruction in terms of post-operative morbidities
timeFrame: May 2018 to February 2021
Secondary outcomes:
measure: Cosmetic outcomes of patients following local perforator flaps in oncoplastic breast conserving surgery
timeFrame: April 2020 to June 2021
measure: Patient satisfaction following local perforator flaps in oncoplastic breast conserving surgery
timeFrame: April 2020 to June 2021
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: The Aga Khan University
state: Sindh
Study officials:
affiliation: Aga Khan University
name: Sana Zeeshan, FCPS, FACS
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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. doi: 10.1056/NEJMoa020989.
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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. doi: 10.1016/j.bjps.2004.04.015.
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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.
citation: BREAST-Q ® VERSION 2.0 © Memorial Sloan Kettering Cancer Center and The University of British Columbia, 2017. All rights reserved
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