Outcomes of Local Perforator Flaps in Oncoplastic Surgery

NCT05389605 | Completed DMC

• 1 other identifier: ERC#2020-3379-10190
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Local Perforator Flaps; Breast Cancer; Oncoplastic Breast Conserving Surgery; BREAST-Q; Breast Surgery

Outcome Measures

Primary Outcomes (4)

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

  Flap anatomy involves the type of flap

  May 2018 to February 2021

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

  May 2018 to February 2021

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

  May 2018 to February 2021

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

  May 2018 to February 2021

Secondary Outcomes (2)

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

  April 2020 to June 2021

• Patient satisfaction following local perforator flaps in oncoplastic breast conserving surgery

  April 2020 to June 2021

Interventions

No intervention was undertaken OTHER

This was an observational study, no intervention was done.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

The Aga Khan University

Karachi, Sindh, 74800, Pakistan

Location

Related Publications (9)

• 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.

  PMID: 7477145 BACKGROUND

• 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.

  PMID: 12393819 BACKGROUND

• 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

  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.

  PMID: 16716957 BACKGROUND

• 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.

  PMID: 15308400 BACKGROUND

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

  PMID: 19730292 BACKGROUND

• 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.

  PMID: 25660559 BACKGROUND

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

  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

  BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sana Zeeshan, FCPS, FACS

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 25, 2022
• Study Start: April 18, 2020
• Primary Completion: June 29, 2021
• Study Completion: June 30, 2021
• Last Updated: May 27, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)