The Significance of Latissimus Dorsi Flap Innervation in Delayed Breast Reconstruction

This study has been completed.
Sponsor:
Information provided by:
Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT01239524
First received: November 10, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted

November 10, 2010
November 10, 2010
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The Significance of Latissimus Dorsi Flap Innervation in Delayed Breast Reconstruction
The Significance of Latissimus Dorsi Flap Innervation in Delayed Breast Reconstruction

Breast reconstruction with a pedicled myocutaneous latissimus dorsi (LD) flap is a widely used reconstruction method. It is controversial if surgical denervation by transecting the thoracodorsal nerve should be performed or not. It is assumed that after denervation the latissimus dorsi muscle will significantly atrophy and lose volume. On the other hand discomforting signs and symptoms from muscle contraction are believed to be prevented if flap is denervated. The aim of the study was prospectively evaluate the influence of LD-flap innervation on the functional and aesthetic outcome of delayed breast reconstruction, and to compare the change in muscle structure in breast MRI and histopathology.

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Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Significance of Latissimus Dorsi Flap Innervation in Delayed Breast Reconstruction
Procedure: denervation of thoracodorsal nerve or saving the nerve
  • DE-group
    surgical denervation by excising 1 cm of proximal thoracodorsal nerve
    Intervention: Procedure: denervation of thoracodorsal nerve or saving the nerve
  • IN group
    thoracodorsal nerve is saved intact
    Intervention: Procedure: denervation of thoracodorsal nerve or saving the nerve
Kääriäinen M, Giordano S, Kauhanen S, Lääperi AL, Mattila P, Helminen M, Kalimo H, Kuokkanen H. The significance of latissimus dorsi flap innervation in delayed breast reconstruction: a prospective randomized study-magnetic resonance imaging and histologic findings. Plast Reconstr Surg. 2011 Dec;128(6):637e-45e. doi: 10.1097/PRS.0b013e318230c544.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
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Inclusion Criteria:

  • delayed LD-flap breast reconstruction, no recurrent disease observed

Exclusion Criteria:

  • recurrent cancer, partial resection of the breast
Female
20 Years to 70 Years
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Contact information is only displayed when the study is recruiting subjects
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NCT01239524
R06075
Yes
Minna Kaariainen/ MD, PhD, Tampere University Hospital, Plastic and Reconstructive surgery department
Tampere University Hospital
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Tampere University Hospital
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP