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The Significance of Latissimus Dorsi Flap Innervation in Delayed Breast Reconstruction

NCT ID: NCT01239524

Last Updated: 2010-11-11

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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

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Conditions

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Significance of Latissimus Dorsi Flap Innervation in Delayed Breast Reconstruction

Keywords

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breast reconstruction, latissimus dorsi flap, thoracodorsal nerve, skeletal muscle disuse, breast MRI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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DE-group

surgical denervation by excising 1 cm of proximal thoracodorsal nerve

Group Type OTHER

denervation of thoracodorsal nerve or saving the nerve

Intervention Type PROCEDURE

IN group

thoracodorsal nerve is saved intact

Group Type OTHER

denervation of thoracodorsal nerve or saving the nerve

Intervention Type PROCEDURE

Interventions

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denervation of thoracodorsal nerve or saving the nerve

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* recurrent cancer, partial resection of the breast
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tampere University Hospital, Plastic and Reconstructive surgery department

References

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Kaariainen M, Giordano S, Kauhanen S, Helminen M, Kuokkanen H. No need to cut the nerve in LD reconstruction to avoid jumping of the breast: a prospective randomized study. J Plast Reconstr Aesthet Surg. 2014 Aug;67(8):1106-10. doi: 10.1016/j.bjps.2014.04.029. Epub 2014 May 13.

Reference Type DERIVED
PMID: 24933238 (View on PubMed)

Kaariainen M, Giordano S, Kauhanen S, Laaperi 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-645e. doi: 10.1097/PRS.0b013e318230c544.

Reference Type DERIVED
PMID: 22094764 (View on PubMed)

Other Identifiers

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R06075

Identifier Type: -

Identifier Source: org_study_id