Significance of Latissimus Dorsi Flap Innervation in Delayed Breast Reconstruction Clinical Trial
Official title:
The Significance of Latissimus Dorsi Flap Innervation in Delayed Breast Reconstruction
| NCT number | NCT01239524 |
| Other study ID # | R06075 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | November 10, 2010 |
| Last updated | November 10, 2010 |
| Verified date | November 2010 |
| Source | Tampere University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Finland: Ethics Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 28 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | |
| Gender | Female |
| Age group | 20 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - delayed LD-flap breast reconstruction, no recurrent disease observed Exclusion Criteria: - recurrent cancer, partial resection of the breast |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Tampere University Hospital |