Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06195865
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2023-12-21
Brief Title:
Autologous vs Implant-based Breast Reconstruction
Sponsor:
Vastra Gotaland Region
Organization:
Vastra Gotaland Region
Study Overview
Official Title:
Autologous vs Implant-based Breast Reconstruction a Partially Randomised Patient Preference Superiority Trial
Status:
RECRUITING
Status Verified Date:
2024-04
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:
GoBreast II
Brief Summary:
Although breast reconstruction is an integral part of breast cancer treatment there is little high-quality evidence to indicate which method is the most effective The objective of this study is to compare implant-based and autologous breast reconstruction in non-radiated patients The primary outcome is patient reported breast-specific quality of lifesatisfaction and the secondary outcomes are complications factors affecting satisfaction and cost-effectiveness Moreover the study aims to improve the evidence for trial decision-making in breast reconstruction Randomized controlled trials RCT are generally thought to provide the most solid scientific evidence but there are significant barriers to conducting RCTs in breast reconstruction making both recruitment and achieving unbiased and generalisable results a challenge The study design partially randomised patient preference trial RPPT might be a way to overcome these challenges In the present study patients who consent to randomisation will be randomised to implant-based and autologous breast reconstruction whereas patients with strong preferences will be able to choose method The study is designed as a superiority trial based on BREAST-Q and 124 participants will be randomised In the preference cohort patients will be included until 62 participants have selected the least popular alternative Follow-up will be 60-months Embedded qualitative studies and within-trial economic evaluation will be performed
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?:
True
Is an FDA AA801 Violation?:
None