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The Significance of Latissimus Dorsi Flap Innervation in Delayed Breast Reconstruction

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ClinicalTrials.gov Identifier: NCT01239524
Recruitment Status : Completed
First Posted : November 11, 2010
Last Update Posted : November 11, 2010
Sponsor:
Information provided by:
Tampere University Hospital

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.

Condition or disease Intervention/treatment Phase
Significance of Latissimus Dorsi Flap Innervation in Delayed Breast Reconstruction Procedure: denervation of thoracodorsal nerve or saving the nerve Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Significance of Latissimus Dorsi Flap Innervation in Delayed Breast Reconstruction

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
DE-group
surgical denervation by excising 1 cm of proximal thoracodorsal nerve
Procedure: denervation of thoracodorsal nerve or saving the nerve
IN group
thoracodorsal nerve is saved intact
Procedure: denervation of thoracodorsal nerve or saving the nerve




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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • recurrent cancer, partial resection of the breast

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Minna Kaariainen/ MD, PhD, Tampere University Hospital, Plastic and Reconstructive surgery department
ClinicalTrials.gov Identifier: NCT01239524     History of Changes
Other Study ID Numbers: R06075
First Posted: November 11, 2010    Key Record Dates
Last Update Posted: November 11, 2010
Last Verified: November 2010

Keywords provided by Tampere University Hospital:
breast reconstruction, latissimus dorsi flap, thoracodorsal nerve, skeletal muscle disuse, breast MRI