Breast Reconstruction in Previously Irradiated Breast

NCT04854525 | Completed

• 1 other identifier: 49/20 b
• Study Type: observational
• Target: 2,150
• Locations: 1 country
• Sites: 1

Brief Summary

For patients with breast cancer subject to a mastectomy, preserving the morphology of the breast with immediate reconstruction is a crucial aspect to preserve the quality of life. There are several types of breast reconstruction: prosthetic in one or two stages and autologous reconstruction. Adjuvant radiotherapy has shown an improvement of the overall survival and of the local control for patients with positive lymph nodes. As a consequence, plastic surgeons come into contact with more patients with a history of irradiation of their breasts than ever before. However, there are few studies with a significant number that evaluate the effect of pre-reconstruction radiotherapy on the three types of reconstruction. The aim of this study is to compare retrospectively these three types of reconstruction techniques to evaluate the impact of breast prior irradiation on the outcome of prosthetic reconstruction.

Conditions

Mammaplasty; Radiotherapy; Complications; Breast Implant; Complications; Transplant Failure

Outcome Measures

Primary Outcomes (1)

• Reconstruction failure

  Complication rate (as hematoma, seroma, prosthetic exposure, skin and fat necrosis) that resulted in explant (prosthetic, expander or flap)

  2 years

Secondary Outcomes (1)

• Reconstruction Complications

  2 years

Study Arms (6)

One Stage Reconstruction With pre-reconstruction Radiotherapy

Radiation: Pre reconstruction Radiotherapy

Two Stage Reconstruction With pre-reconstruction Radiotherapy

Radiation: Pre reconstruction Radiotherapy

Autologous Reconstruction With pre-reconstruction Radiotherapy

Radiation: Pre reconstruction Radiotherapy

One Stage Reconstruction Without pre-reconstruction Radiotherapy

Two Stage Reconstruction Without pre-reconstruction Radiotherapy

Autologous Reconstruction Without pre-reconstruction Radiotherapy

Interventions

Pre reconstruction Radiotherapy RADIATION

Previous PMRT

Autologous Reconstruction With pre-reconstruction Radiotherapy; One Stage Reconstruction With pre-reconstruction Radiotherapy; Two Stage Reconstruction With pre-reconstruction Radiotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients of some Breast Units in Italy

You may qualify if:

• Patients subjected to mastectomy and immediate reconstruction directly with prostheses, in two times and by autologue flaps (TRAM, Latissimus Dorsi Flap, DIEP and any other method)

You may not qualify if:

• Delayed prosthetic reconstruction

Sponsors & Collaborators

• Humanitas Clinical and Research Center: lead
• Marco Klinger: collaborator
• Marta Scorsetti: collaborator
• Davide Franceschini: collaborator
• Emanuela Morenghi: collaborator

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, Milan, 20089, Italy

Location

Related Publications (10)

• Al-Ghazal SK, Fallowfield L, Blamey RW. Comparison of psychological aspects and patient satisfaction following breast conserving surgery, simple mastectomy and breast reconstruction. Eur J Cancer. 2000 Oct;36(15):1938-43. doi: 10.1016/s0959-8049(00)00197-0.

  PMID: 11000574 BACKGROUND

• Cordeiro PG. Breast reconstruction after surgery for breast cancer. N Engl J Med. 2008 Oct 9;359(15):1590-601. doi: 10.1056/NEJMct0802899. No abstract available.

  PMID: 18843123 BACKGROUND

• Recht A, Comen EA, Fine RE, Fleming GF, Hardenbergh PH, Ho AY, Hudis CA, Hwang ES, Kirshner JJ, Morrow M, Salerno KE, Sledge GW Jr, Solin LJ, Spears PA, Whelan TJ, Somerfield MR, Edge SB. Postmastectomy Radiotherapy: An American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology Focused Guideline Update. Pract Radiat Oncol. 2016 Nov-Dec;6(6):e219-e234. doi: 10.1016/j.prro.2016.08.009. Epub 2016 Sep 19.

  PMID: 27659727 BACKGROUND

• Yanko-Arzi R, Cohen MJ, Braunstein R, Kaliner E, Neuman R, Brezis M. Breast reconstruction: complication rate and tissue expander type. Aesthetic Plast Surg. 2009 Jul;33(4):489-96. doi: 10.1007/s00266-008-9192-0. Epub 2008 Jun 6.

  PMID: 18535851 BACKGROUND

• Christante D, Pommier SJ, Diggs BS, Samuelson BT, Truong A, Marquez C, Hansen J, Naik AM, Vetto JT, Pommier RF. Using complications associated with postmastectomy radiation and immediate breast reconstruction to improve surgical decision making. Arch Surg. 2010 Sep;145(9):873-8. doi: 10.1001/archsurg.2010.170.

  PMID: 20855758 BACKGROUND

• Berry T, Brooks S, Sydow N, Djohan R, Nutter B, Lyons J, Dietz J. Complication rates of radiation on tissue expander and autologous tissue breast reconstruction. Ann Surg Oncol. 2010 Oct;17 Suppl 3:202-10. doi: 10.1245/s10434-010-1261-3. Epub 2010 Sep 19.

  PMID: 20853034 BACKGROUND

• Chang DW, Barnea Y, Robb GL. Effects of an autologous flap combined with an implant for breast reconstruction: an evaluation of 1000 consecutive reconstructions of previously irradiated breasts. Plast Reconstr Surg. 2008 Aug;122(2):356-362. doi: 10.1097/PRS.0b013e31817d6303.

  PMID: 18626350 BACKGROUND

• Ascherman JA, Hanasono MM, Newman MI, Hughes DB. Implant reconstruction in breast cancer patients treated with radiation therapy. Plast Reconstr Surg. 2006 Feb;117(2):359-65. doi: 10.1097/01.prs.0000201478.64877.87.

  PMID: 16462313 BACKGROUND

• Nahabedian MY, Tsangaris T, Momen B, Manson PN. Infectious complications following breast reconstruction with expanders and implants. Plast Reconstr Surg. 2003 Aug;112(2):467-76. doi: 10.1097/01.PRS.0000070727.02992.54.

  PMID: 12900604 BACKGROUND

• Caviggioli F, Maione L, Klinger F, Lisa A, Klinger M. Autologous Fat Grafting Reduces Pain in Irradiated Breast: A Review of Our Experience. Stem Cells Int. 2016;2016:2527349. doi: 10.1155/2016/2527349. Epub 2015 Dec 29.

  PMID: 26858758 BACKGROUND

Study Officials

• Marco Klinger

  Humanitas Hospital, Italy

  STUDY DIRECTOR

• Davide Franceschini

  Humanitas Hospital, Italy

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: April 22, 2021
• Study Start: June 6, 2020
• Primary Completion: November 23, 2020
• Study Completion: January 25, 2021
• Last Updated: April 22, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)