Outcomes of Local Perforator Flaps in Oncoplastic Surgery

NCT ID: NCT05389605

Last Updated: 2022-05-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-18
• Study Completion Date: 2021-06-30

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.

Conditions

Breast Tumor; Perforator Flap; Breast Cancer; Oncoplasty; Breast-Q

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Interventions

No intervention was undertaken

This was an observational study, no intervention was done.

Intervention Type: OTHER

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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aga Khan University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Sana Zeeshan

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sana Zeeshan, FCPS, FACS

Role: PRINCIPAL_INVESTIGATOR

Aga Khan University

Locations

The Aga Khan University

Karachi, Sindh, Pakistan

Countries

Pakistan

References

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Reference Type: BACKGROUND

PMID: 7477145 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12393819 (View on PubMed)

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

Reference Type: BACKGROUND

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. doi: 10.1016/j.bjps.2006.01.006. Epub 2006 Mar 22.

Reference Type: BACKGROUND

PMID: 16716957 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15308400 (View on PubMed)

Losken A, Hamdi M. Partial breast reconstruction: current perspectives. Plast Reconstr Surg. 2009 Sep;124(3):722-736. doi: 10.1097/PRS.0b013e3181b179d2.

Reference Type: BACKGROUND

PMID: 19730292 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25660559 (View on PubMed)

BREAST-Q ® VERSION 2.0 © Memorial Sloan Kettering Cancer Center and The University of British Columbia, 2017. All rights reserved

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ERC#2020-3379-10190

Identifier Type: -

Identifier Source: org_study_id