Patient Satisfaction Clinical Trial
— RMSU-LDPEMOfficial 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
Verified date | January 2024 |
Source | University Hospital, Brest |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 22 |
Est. completion date | February 28, 2024 |
Est. primary completion date | February 28, 2024 |
Accepts healthy volunteers | |
Gender | Female |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Breast reconstruction using a TDAP or MSLD flap between January 1, 2018 and December 31, 2022 - Major - Non opposition - Women with social security number Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
France | Chu Brest | Brest |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Brest |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient satisfaction | patient satisfaction by using BREAST questionnaire (0 to 100, and 100 is the best score) | 5 years | |
Secondary | 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)) | 5 years |
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