The Significance of Latissimus Dorsi Flap Innervation in Delayed Breast Reconstruction

November 10, 2010 updated by: Tampere University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • recurrent cancer, partial resection of the breast

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 10, 2010

First Submitted That Met QC Criteria

November 10, 2010

First Posted (Estimate)

November 11, 2010

Study Record Updates

Last Update Posted (Estimate)

November 11, 2010

Last Update Submitted That Met QC Criteria

November 10, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R06075

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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