Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06319157
Status:
RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-03-13
Brief Title:
Minimal Access Versus Conventional Latissimus Dorsi Flap Harvest for Breast Reconstruction
Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Overview
Official Title:
A Randomized Controlled Study of Minimal Access Latissimus Dorsi Flap Harvest for Breast Reconstruction Versus Conventional Approaches in the Treatment of Early Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
For patients refusing implants for breast reconstruction after cancer surgery autologous tissue flap reconstruction using the latissimus dorsi muscle is an alternative Conventional surgery leaves a long incision on the back affecting aesthetics and quality of life Minimal access techniques result in a smaller more concealable scar While previous studies suggest its safety and effectiveness most are retrospective To further validate patient satisfaction and short-term outcomes a prospective randomized controlled trial comparing minimal access with conventional surgery is planned The primary endpoint is Breast Q-satisfaction with back score at 6 months Secondary outcomes include other Breast Q subscales surgical metrics and complications The study aims to enroll 94 patients in total providing evidence for surgical decision-making in breast cancer reconstruction
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None