Outcomes of Local Perforator Flaps in Oncoplastic Surgery

Sponsor
Aga Khan University (Other)
Overall Status
Completed
CT.gov ID
NCT05389605
Collaborator
(none)
25
1
14.4
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention was undertaken

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.

Study Design

Study Type:
Observational
Actual Enrollment :
25 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
A Single Centre Experience of Local Perforator Flaps in Oncoplastic Breast Surgery; a Cross-sectional Study
Actual Study Start Date :
Apr 18, 2020
Actual Primary Completion Date :
Jun 29, 2021
Actual Study Completion Date :
Jun 30, 2021

Outcome Measures

Primary Outcome Measures

  1. Surgical techniques of pedicled local fasciocutaneous perforator flaps in partial breast reconstruction in terms of flap anatomy [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 [May 2018 to February 2021]

  3. Surgical techniques of pedicled local fasciocutaneous perforator flaps in partial breast reconstruction in terms of operative time [May 2018 to February 2021]

  4. Surgical techniques of pedicled local fasciocutaneous perforator flaps in partial breast reconstruction in terms of post-operative morbidities [May 2018 to February 2021]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Aga Khan University Karachi Sindh Pakistan 74800

Sponsors and Collaborators

  • Aga Khan University

Investigators

  • Principal Investigator: Sana Zeeshan, FCPS, FACS, Aga Khan University

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Dr. Sana Zeeshan, Assistant Professor, Aga Khan University
ClinicalTrials.gov Identifier:
NCT05389605
Other Study ID Numbers:
  • ERC#2020-3379-10190
First Posted:
May 25, 2022
Last Update Posted:
May 27, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. Sana Zeeshan, Assistant Professor, Aga Khan University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 27, 2022