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

NCT06230250 | Unknown

• 1 other identifier: 29BREC23.0196 - RMSU-LDPEM
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Patient Satisfaction

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction

  patient satisfaction by using BREAST questionnaire (0 to 100, and 100 is the best score)

  5 years

Secondary Outcomes (1)

• Patient characteristics

  5 years

Eligibility Criteria

• Sex: female
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women who underwent unilateral secondary total breast reconstruction using a TDAP or MSLD flap.

You may qualify if:

• Breast reconstruction using a TDAP or MSLD flap between January 1, 2018 and December 31, 2022
• Major
• Non opposition
• Women with social security number

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

Chu Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 30, 2024
• Study Start: October 1, 2023
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement

Locations

FR (1)