Adjuvant Radiotherapy's Effect on One and Two Stages Prosthetic Breast Reconstruction and on Autologous Reconstruction
NCT ID: NCT04783818
Last Updated: 2021-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
3200 participants
OBSERVATIONAL
2020-06-06
2021-01-25
Brief Summary
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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.
Despite the undoubted cancer benefits, several studies have shown the negative impact of radiotherapy on breast reconstruction.
However, there are few studies with a significant number that evaluate the effect of radiotherapy on the three types of reconstruction.
In particular, given the extreme variability in clinical approaches, there is no certainty about the best reconstructive timing compared to radiotherapy, the iterations with dermic matrices as well as the usefulness of ancillary procedures such as autologous adipose grafting.
The aim of this study is to compare retrospectively these three types of reconstruction techniques to evaluate the effect of radiotherapy on different reconstructive modes.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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One Stage Reconstruction With Adjuvant Radiotherapy
Adjuvant Radiotherapy
PMRT
Two Stage Reconstruction With Adjuvant Radiotherapy
Adjuvant Radiotherapy
PMRT
Autologous Reconstruction With Adjuvant Radiotherapy
Adjuvant Radiotherapy
PMRT
One Stage Reconstruction Without Adjuvant Radiotherapy
No interventions assigned to this group
Two Stage Reconstruction Without Adjuvant Radiotherapy
No interventions assigned to this group
Autologous Reconstruction Without Adjuvant Radiotherapy
No interventions assigned to this group
Interventions
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Adjuvant Radiotherapy
PMRT
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
80 Years
FEMALE
No
Sponsors
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Marco Klinger
UNKNOWN
Marta Scorsetti
UNKNOWN
Davide Franceschini
UNKNOWN
Emanuela Morenghi
UNKNOWN
Humanitas Clinical and Research Center
OTHER
Responsible Party
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Andrea Lisa
Principal Investigator
Principal Investigators
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Marco Klinger
Role: STUDY_DIRECTOR
Humanitas Hospital, Italy
Davide Franceschini
Role: STUDY_CHAIR
Humanitas Hospital, Italy
Locations
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Istituto Clinico Humanitas
Rozzano, Milan, Italy
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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49/20
Identifier Type: -
Identifier Source: org_study_id
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