Patient SatisfactionRMSU-LDPEMNCT06230250
Unilateral Secondary Breast Reconstruction Using a Muscle-sparing Pedicled Dorsal Flap After Breast Cancer
An observational study of Patient Satisfaction, run by University Hospital, Brest at 1 site in France.
Trial summary
The use of pedicled dorsal flaps sparing the latissimus dorsi muscle (TDAP and MSLD flap) is a well-described reconstruction method in breast reconstruction after breast cancer. However, little data exists regarding patient satisfaction after this surgery. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Patient Satisfaction
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2023to 28 Feb 2024
- 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
- Child, Adult, Older adult
Study population: Women who underwent unilateral secondary total breast reconstruction using a TDAP or MSLD flap.
Who may be able to join
- Breast reconstruction using a TDAP or MSLD flap between January 1, 2018 and December 31, 2022
- Major
- Non opposition
- Women with social security number
Who cannot join
- Bilateral reconstruction
- Partial reconstruction
- Immediate reconstruction
- Prophylactic reconstruction
- Women who did'nt have a breast cancer
- Women who don't finish their reconstruction
- Women who don't want participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Unilateral Secondary Breast Reconstruction Using a Muscle-sparing Pedicled Dorsal Flap in Patients With a History of Total Mastectomy for Breast Cancer Single-centre Observational Study
The use of pedicled dorsal flaps sparing the latissimus dorsi muscle (TDAP and MSLD flap) is a well-described reconstruction method in breast reconstruction after breast cancer. However, little data exists regarding patient satisfaction after this surgery. The main objective of this study was to evaluate patient satisfaction after unilateral total secondary breast reconstruction using a TDAP or MSLD flap.
- Conditions
- Patient Satisfaction
- Medical subject headings
- Patient Satisfaction
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
patient satisfaction by using BREAST questionnaire (0 to 100, and 100 is the best score)
Measured: 5 years
Secondary outcomes (1)
Patient characteristics
Post-operative complications (number of hematoma, number of infection, number of seroma, number of flap lost), duration of the reconstruction (number of days), nature of additional interventions (number of lipofilling, symmetrization (yes or no), prothesis (yes or no))
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start1 Oct 2023
- Primary completion28 Feb 2024 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Retrospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230250
- Sponsor's protocol ID
- 29BREC23.0196 - RMSU-LDPEM
- Acronym
- RMSU-LDPEM
- Status last verified
- Jan 2024
- First submitted
- 8 Jan 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unilateral Secondary Breast Reconstruction Using a Muscle-sparing Pedicled Dorsal Flap in Patients With a History of Total Mastectomy for Breast Cancer Single-centre Observational Study
- ClinicalTrials.gov ID
- NCT06230250
- Acronym / sponsor ID
- RMSU-LDPEM / 29BREC23.0196 - RMSU-LDPEM
- Conditions
- Patient Satisfaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 30 Jan 2024 (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 use of pedicled dorsal flaps sparing the latissimus dorsi muscle (TDAP and MSLD flap) is a well-described reconstruction method in breast reconstruction after breast cancer. However, little data exists regarding patient satisfaction after this surgery. The main objective of this study was to evaluate patient satisfaction after unilateral total secondary breast reconstruction using a TDAP or MSLD flap.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- Women who underwent unilateral secondary total breast reconstruction using a TDAP or MSLD flap.
Key inclusion criteria (4 listed)
- Breast reconstruction using a TDAP or MSLD flap between January 1, 2018 and December 31, 2022
- Major
- Non opposition
- Women with social security number
Key exclusion criteria (7 listed)
- Bilateral reconstruction
- Partial reconstruction
- Immediate reconstruction
- Prophylactic reconstruction
- Women who did'nt have a breast cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient satisfaction
Time frame: 5 years
patient satisfaction by using BREAST questionnaire (0 to 100, and 100 is the best score)
1 secondary outcome
Patient characteristics
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
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 Patient Satisfaction, run by University Hospital, Brest at 1 site in France.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 28 Feb 2024. 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 France. 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?
Results are not available in the source record.
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?
Patient satisfaction (time frame: 5 years). 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 28 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.