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

Tracking Information
First Received Date ^ICMJE	November 10, 2010
Last Updated Date	November 10, 2010
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Significance of Latissimus Dorsi Flap Innervation in Delayed Breast Reconstruction
Official Title ^ICMJE	The Significance of Latissimus Dorsi Flap Innervation in Delayed Breast Reconstruction
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Significance of Latissimus Dorsi Flap Innervation in Delayed Breast Reconstruction
Intervention ^ICMJE	Procedure: denervation of thoracodorsal nerve or saving the nerve
Study Arm (s)	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
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	28
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: delayed LD-flap breast reconstruction, no recurrent disease observed Exclusion Criteria: recurrent cancer, partial resection of the breast
Gender	Female
Ages	20 Years to 70 Years
Accepts Healthy Volunteers	Not Provided
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01239524
Other Study ID Numbers ^ICMJE	R06075
Has Data Monitoring Committee	Yes
Responsible Party	Minna Kaariainen/ MD, PhD, Tampere University Hospital, Plastic and Reconstructive surgery department
Study Sponsor ^ICMJE	Tampere University Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Tampere University Hospital
Verification Date	November 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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