Significance of Latissimus Dorsi Flap Innervation in Delayed Breast ReconstructionPhase 3NCT01239524
The Significance of Latissimus Dorsi Flap Innervation in Delayed Breast Reconstruction
A Phase 3 study testing denervation of thoracodorsal nerve or saving the nerve in people with Significance of Latissimus Dorsi Flap Innervation in Delayed Breast Reconstruction, run by Tampere University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Significance of Latissimus Dorsi Flap Innervation in Delayed Breast Reconstruction
- What is being tested?
- denervation of thoracodorsal nerve or saving the nerve
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Women only
- Adult, Older adult
Who may be able to join
- delayed LD-flap breast reconstruction, no recurrent disease observed
Who cannot join
- recurrent cancer, partial resection of the breast
About this study
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.
- Being tested
- denervation of thoracodorsal nerve or saving the nerve
- Keywords
- breast reconstruction, latissimus dorsi flap, thoracodorsal nerve, skeletal muscle disuse, breast MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
denervation of thoracodorsal nerve or saving the nerveProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| DE-group | Other | surgical denervation by excising 1 cm of proximal thoracodorsal nerve Receives: Procedure: denervation of thoracodorsal nerve or saving the nerve |
| IN group | Other | thoracodorsal nerve is saved intact Receives: Procedure: denervation of thoracodorsal nerve or saving the nerve |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Significance of Latissimus Dorsi Flap Innervation in Delayed Breast ReconstructionStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01239524
- Sponsor's protocol ID
- R06075
- Status last verified
- Nov 2010
- First submitted
- 10 Nov 2010
- Last updated
- 11 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24933238Kaariainen 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.
PubMed 22094764
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Significance of Latissimus Dorsi Flap Innervation in Delayed Breast Reconstruction
- ClinicalTrials.gov ID
- NCT01239524
- Acronym / sponsor ID
- R06075
- Keywords
- breast reconstruction, latissimus dorsi flap, thoracodorsal nerve, skeletal muscle disuse, breast MRI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- First posted
- 11 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DE-group | Other | Procedure: denervation of thoracodorsal nerve or saving the nervesurgical denervation by excising 1 cm of proximal thoracodorsal nerve |
| IN group | Other | Procedure: denervation of thoracodorsal nerve or saving the nervethoracodorsal nerve is saved intact |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- delayed LD-flap breast reconstruction, no recurrent disease observed
Key exclusion criteria (1 listed)
- recurrent cancer, partial resection of the breast
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| denervation of thoracodorsal nerve or saving the nerve | Procedure or surgery | DE-group, IN group |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2010.
- Derived from this study: PubMed 24933238Kaariainen 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.
- Derived from this study: PubMed 22094764Kaariainen 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing denervation of thoracodorsal nerve or saving the nerve in people with Significance of Latissimus Dorsi Flap Innervation in Delayed Breast Reconstruction, run by Tampere University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01239524, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2010.