AzTrials
AzTrials

Breast TumorNCT05389605

Outcomes of Local Perforator Flaps in Oncoplastic Surgery

An observational study of Breast Tumor and Perforator Flap, run by Aga Khan University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Breast Tumor, Perforator Flap, Breast Cancer
How many people
25 participants
Where
1 sitePakistan
Study dates
18 Apr 2020to 30 Jun 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • All female patients suitable for breast conservation who underwent a pedicled fasciocutaneous perforator flap for immediate partial breast reconstruction at the breast surgery section

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • The Aga Khan University

    Karachi, Sindh, 74800

Other trials in Pakistan

About this study

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

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.

Read the 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.

Being tested
No intervention was undertaken
Keywords
Local Perforator Flaps, Breast Cancer, Oncoplastic Breast Conserving Surgery, BREAST-Q, Breast Surgery
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No intervention was undertakenOther

    This was an observational study, no intervention was done.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Flap anatomy involves the type of flap

    Measured: May 2018 to February 2021

  2. Surgical techniques of pedicled local fasciocutaneous perforator flaps in partial breast reconstruction in terms of location of perforators

    Measured: May 2018 to February 2021

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

    Measured: May 2018 to February 2021

  4. Surgical techniques of pedicled local fasciocutaneous perforator flaps in partial breast reconstruction in terms of post-operative morbidities

    Measured: May 2018 to February 2021

Secondary outcomes (2)

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

    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.

    Measured: April 2020 to June 2021

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

    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.

    Measured: April 2020 to June 2021

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2022
  2. Study start18 Apr 2020
  3. Primary completion29 Jun 2021
  4. Study completion30 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05389605
Sponsor's protocol ID
ERC#2020-3379-10190
Status last verified
May 2022
First submitted
10 May 2022
Last updated
27 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fisher B, Anderson S, Redmond CK, Wolmark N, Wickerham DL, Cronin WM. Reanalysis and results after 12 years of follow-up in a randomized clinical trial comparing total mastectomy with lumpectomy with or without irradiation in the treatment of breast cancer. N Engl J Med. 1995 Nov 30;333(22):1456-61. doi: 10.1056/NEJM199511303332203.

    PubMed 7477145

  • 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.

    PubMed 12393819

  • 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

  • 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.

    PubMed 16716957

  • 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.

    PubMed 15308400

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

    PubMed 19730292

  • 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.

    PubMed 25660559

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

  • 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

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Tumor and Perforator Flap, run by Aga Khan University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surgical techniques of pedicled local fasciocutaneous perforator flaps in partial breast reconstruction in terms of flap anatomy (time frame: May 2018 to February 2021). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05389605, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.

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