Breast CancerNCT03106233
Lateral Thigh Perforator (LTP) Flap for Autologous Breast Reconstruction
An observational study of Breast Cancer, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The lateral thigh perforator (LTP) flap was previously introduced as an alternative flap for autologous breast reconstruction when the abdomen is not suitable as a donor site. In this prospective study all LTP flap breast reconstructions that have been performed since September 2012 are analyzed. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- LTP flap
- Type of treatment
- Surgery or procedure
- How many people
- 86 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2012to Dec 2016
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: All female patients who opted for autologous breast reconstruction but who required an alternate flap than the deep inferior epigastric artery perforator (DIEP) flap.
Who may be able to join
- Lateral thigh region suitable as a donor site
- Abdomen not suitable as donor site
- Informed consent
Who cannot join
- Pre-operative imaging showing no suitable perforators
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg, 6229 HX
About this study
Official title: The Lateral Thigh Perforator (LTP) Flap for Autologous Breast Reconstruction: A Prospective Analysis of 138 Flaps
The lateral thigh perforator (LTP) flap was previously introduced as an alternative flap for autologous breast reconstruction when the abdomen is not suitable as a donor site. In this prospective study all LTP flap breast reconstructions that have been performed since September 2012 are analyzed. In addition, the surgical refinements that were introduced over the years are reported.
- Conditions
- Breast Cancer
- Being tested
- LTP flap
- Keywords
- Breast reconstruction, Perforator flap, Microsurgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LTP flapProcedure or surgery
Also called Lateral thigh perforator flap, Septocutaneous tensor fasciae latae (sc-TFL) flap
A flap is harvested from the upper lateral thigh region based on septocutaneous perforators located in the posterior septum between the tensor fascia latae and gluteus medius muscles.
| Study group | Role | What they receive |
|---|---|---|
| LTP flap breast reconstruction | All consecutive patients who underwent LTP flap breast reconstructions (unilateral, bilateral or stacked unilateral) between September 2012 and November 2016 at three centers in Maastricht, the Netherlands, and New York and New Orleans, the United States, were included. Autologous breast reconstruction was performed by using the upper lateral thigh region as a donor site. Receives: Procedure: LTP flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recipient- and donor-site complications
Recipient site: Total flap loss, partial flap loss, venous congestion, infection, hematoma, seroma, fat necrosis and wound complications. Donor site: Infection, hematoma, seroma, fat necrosis, wound complications.
Measured: Through study completion up to an average of 12 months post-operatively
Secondary outcomes (1)
Flap re-explorations
Total number of flaps that required a re-exploration because of arterial or venous insufficiency, hematoma or kinking of the pedicle.
Measured: Through study completion up to an average of 12 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study startSep 2012
- Primary completionNov 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rene van der Hulst, Maastricht University Medical Center
- Investigators
- Stefania Tuinder, MD, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106233
- Sponsor's protocol ID
- METC 14-5-095
- Status last verified
- Apr 2017
- First submitted
- 9 Feb 2017
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Lateral Thigh Perforator (LTP) Flap for Autologous Breast Reconstruction: A Prospective Analysis of 138 Flaps
- ClinicalTrials.gov ID
- NCT03106233
- Acronym / sponsor ID
- METC 14-5-095
- Conditions
- Breast Cancer
- Keywords
- Breast reconstruction, Perforator flap, Microsurgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Sep 2012 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 10 Apr 2017 (actual)
- 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.
The lateral thigh perforator (LTP) flap was previously introduced as an alternative flap for autologous breast reconstruction when the abdomen is not suitable as a donor site. In this prospective study all LTP flap breast reconstructions that have been performed since September 2012 are analyzed. In addition, the surgical refinements that were introduced over the years are reported.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LTP flap breast reconstruction | – | Procedure: LTP flapAll consecutive patients who underwent LTP flap breast reconstructions (unilateral, bilateral or stacked unilateral) between September 2012 and November 2016 at three centers in Maastricht, the Netherlands, and New York and New Orleans, the United States, were included. Autologous breast reconstruction was performed by using the upper lateral thigh region as a donor site. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All female patients who opted for autologous breast reconstruction but who required an alternate flap than the deep inferior epigastric artery perforator (DIEP) flap.
Key inclusion criteria (3 listed)
- Lateral thigh region suitable as a donor site
- Abdomen not suitable as donor site
- Informed consent
Key exclusion criteria (1 listed)
- Pre-operative imaging showing no suitable perforators
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 |
|---|---|---|
| LTP flapAlso: Lateral thigh perforator flap, Septocutaneous tensor fasciae latae (sc-TFL) flapA flap is harvested from the upper lateral thigh region based on septocutaneous perforators located in the posterior septum between the tensor fascia latae and gluteus medius muscles. | Procedure or surgery | LTP flap breast reconstruction |
Primary outcome
Recipient- and donor-site complications
Time frame: Through study completion up to an average of 12 months post-operatively
Recipient site: Total flap loss, partial flap loss, venous congestion, infection, hematoma, seroma, fat necrosis and wound complications. Donor site: Infection, hematoma, seroma, fat necrosis, wound complications.
1 secondary outcome
Flap re-explorations
Time frame: Through study completion up to an average of 12 months post-operatively
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 10 Apr 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Stefania Tuinder, MD, PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Maastricht University Medical Center at 1 site in Netherlands.
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 3 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 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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.
What does the primary outcome measure?
Recipient- and donor-site complications (time frame: Through study completion up to an average of 12 months post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2017.