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
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Significance of Latissimus Dorsi Flap Innervation in Delayed Breast Reconstruction

Resource links provided by NLM:


Further study details as provided by Tampere University Hospital:

Enrollment: 28
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Tampere University Hospital

Additional 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
Study First Received: November 10, 2010
Last Updated: November 10, 2010
Health Authority: Finland: Ethics Committee

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

ClinicalTrials.gov processed this record on September 22, 2014