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OpenTrials
Completed

NCT Number: NCT05389605

Outcomes of Local Perforator Flaps in Oncoplastic Surgery

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.

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

The Aga Khan University

Karachi, Sindh, 74800, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention was undertaken

Other

This was an observational study, no intervention was done.

Primary outcomes

  1. Surgical techniques of pedicled local fasciocutaneous perforator flaps in partial breast reconstruction in terms of flap anatomy

    Time frame: May 2018 to February 2021

    Flap anatomy involves the type of flap

  2. 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

  3. Surgical techniques of pedicled local fasciocutaneous perforator flaps in partial breast reconstruction in terms of operative time

    Time frame: May 2018 to February 2021

  4. 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

Secondary outcomes

  1. Cosmetic outcomes of patients following local perforator flaps in oncoplastic breast conserving surgery

    Time frame: April 2020 to June 2021

    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.

  2. Patient satisfaction following local perforator flaps in oncoplastic breast conserving surgery

    Time frame: April 2020 to June 2021

    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.

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Registry information

Official study title

A Single Centre Experience of Local Perforator Flaps in Oncoplastic Breast Surgery; a Cross-sectional Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 25, 2022
Registry last updated
May 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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