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NCT06230250 Clinical Trial

Unilateral Secondary Breast Reconstruction Using a Muscle-sparing Pedicled Dorsal Flap After Breast Cancer

Patient Satisfaction Clinical Trial

— RMSU-LDPEM  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06230250
Other study ID # 29BREC23.0196 - RMSU-LDPEM
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 1, 2023
Est. completion date February 28, 2024

Study information
Verified date January 2024
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. The main objective of this study was to evaluate patient satisfaction after unilateral total secondary breast reconstruction using a TDAP or MSLD flap.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Chu Brest Brest

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome
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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