NCT00845078|Withdrawn
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Sponsor study identifier
observational
0
0 countries
N/A
Study Start
December 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
Not reported
Date not reportedThis study examines the aesthetic outcomes of breast reconstruction after mastectomy for breast cancer in patients who require post-mastectomy radiation treatment. Patients will undergo autologous tissue breast reconstruction either in immediate fashion, prior to radiation treatment, or in delayed fashion, after radiation treatment. Both approaches are acceptable and are practiced clinically. this will be an observational prospective cohort study. The investigators hypothesize that immediate autologous reconstruction patients who undergo subsequent radiation therapy have equivalent aesthetic outcome when compared to those in whom reconstruction is delayed until after radiation, with the additional benefit of avoiding the psychological side effects of breast amputation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2008
Date type not reportedThis date has not been verified as actual or estimated.
February 13, 2009
Actual (reported)February 16, 2009
Actual (reported)Aesthetic breast scores
preoperative, 1 month, 6 months, 12 months, 24 months
Quality of life (SF36)
preoperative, 1 month, 6 months, 12 months, 24 months
Patient Breast aesthetic perception (BR23)
preoperative, 1 month, 6 months, 12 months, 24 months
Immediate reconstruction followed by radiation therapy
Radiation therapy followed by delayed reconstruction
Patients undergoing mastectomy and radiation for breast cancer, who desire breast reconstruction after mastectomy
Edsander-Nord A, Brandberg Y, Wickman M. Quality of life, patients' satisfaction, and aesthetic outcome after pedicled or free TRAM flap breast surgery. Plast Reconstr Surg. 2001 Apr 15;107(5):1142-53; discussion 1154-5. doi: 10.1097/00006534-200104150-00007.
Tran NV, Chang DW, Gupta A, Kroll SS, Robb GL. Comparison of immediate and delayed free TRAM flap breast reconstruction in patients receiving postmastectomy radiation therapy. Plast Reconstr Surg. 2001 Jul;108(1):78-82. doi: 10.1097/00006534-200107000-00013.
Julio A Clavijo-Alvarez, MD
University of Pittsburgh
Michael L Gimbel, MD
University of Pittsburgh
0 participants (actual enrollment reported by the registry).
First Submitted
February 13, 2009
First Posted
February 16, 2009
Study Start
December 2008
Date type not reportedThis date has not been verified as actual or estimated.
ATM Variants in Radiotherapy Patients
Contact the study team to confirm eligibility.
Tran NV, Evans GR, Kroll SS, Baldwin BJ, Miller MJ, Reece GP, Robb GL. Postoperative adjuvant irradiation: effects on tranverse rectus abdominis muscle flap breast reconstruction. Plast Reconstr Surg. 2000 Aug;106(2):313-7; discussion 318-20. doi: 10.1097/00006534-200008000-00011.
Kroll SS, Robb GL, Reece GP, Miller MJ, Evans GR, Baldwin BJ, Wang B, Schusterman MA. Does prior irradiation increase the risk of total or partial free-flap loss? J Reconstr Microsurg. 1998 May;14(4):263-8. doi: 10.1055/s-2007-1000179.
Kroll SS, Coffey JA Jr, Winn RJ, Schusterman MA. A comparison of factors affecting aesthetic outcomes of TRAM flap breast reconstructions. Plast Reconstr Surg. 1995 Sep;96(4):860-4. doi: 10.1097/00006534-199509001-00015.
Last Updated
April 27, 2017
Record last verified: 2009-02
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