NCT04356235View on ClinicalTrials.gov

Examining and Comparing the Temporal Changes and Results of Cosmetic, Quality of Life and Patient Satisfaction Achieved With Immediate and Delayed-immediate Implant-based Breast Reconstruction Procedures and Contralateral Symmetrization Techniques

RecruitingOBSERVATIONAL
Enrollment

528

Participants

Timeline

Start Date

April 27, 2020

Primary Completion Date

April 10, 2022

Study Completion Date

April 10, 2027

Conditions
Mastectomy; LymphedemaBreast CancerQuality of Life
Interventions
PROCEDURE

A: expander-silicone implant exchange and contralateral symmetrization with mastopexy and if needed with volume reduction

expander-silicone implant exchange and contralateral symmetrization with mastopexy and if needed with volume reduction

PROCEDURE

B: expander-silicone implant exchange with contralateral symmetrization with mastopexy and Ultrapro sling

expander-silicone implant exchange with contralateral symmetrization with mastopexy and Ultrapro sling

PROCEDURE

C: expander-silicone implant exchange and contralateral symmetrization with mastopexy and silicone implant augmentation

expander-silicone implant exchange and contralateral symmetrization with mastopexy and silicone implant augmentation

PROCEDURE

D: expander-silicone implant exchange and contralateral symmetrization with mastopexy and Utrapro sling and silicone implant augmentation

expander-silicone implant exchange and contralateral symmetrization with mastopexy and Utrapro sling and silicone implant augmentation

PROCEDURE

E: unilateral simple mastectomy

unilateral simple mastectomy

PROCEDURE

F: after bilateral SSM, ASM, NSM, expander-implant exchange

after bilateral SSM, ASM, NSM, expander-implant exchange

Trial Locations (1)

1122

RECRUITING

National Institute of Oncology, Budapest

All Listed Sponsors
lead

National Institute of Oncology, Hungary

OTHER