Clinical Trials Directory

Trials / Completed

CompletedNCT05389605

Outcomes of Local Perforator Flaps in Oncoplastic Surgery

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

Status
Completed
Phase
Study type
Observational
Enrollment
25 (actual)
Sponsor
Aga Khan University · Academic / Other
Sex
Female
Age
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
OTHERNo intervention was undertakenThis was an observational study, no intervention was done.

Timeline

Start date
2020-04-18
Primary completion
2021-06-29
Completion
2021-06-30
First posted
2022-05-25
Last updated
2022-05-27

Locations

1 site across 1 country: Pakistan

Source: ClinicalTrials.gov record NCT05389605. Inclusion in this directory is not an endorsement.