NCT04888351

Immediate Breast Reconstruction's Increasing

Mastectomy and Breast Cancer : Follow-up of IBR's Rate and Study of Complications as Compared to Delayed Reconstructions Between 2016 and 2020 in Lyon

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 215 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Mastectomy in breast cancer is still a way of treatment. Nowadays, the goal is to improve reconstruction's technicals. Immediate Breast Reconstruction (IBR) is one of them, largely used in United States but less in France. However, IGR (Insitut Gustave Roussey) in Paris just wrote a new protocole wich allows more IBR by including more patients. This study aims to compare complications in 2 groups: mastectomies followed by IBR and mastectomies without IBR. The second goal will try to estimate the proportion of eligible's patients to IBR, and to analyse their surgicals and oncologicals risk factors

Conditions

• Breast Reconstruction
• Breast Cancer

Interventions

Type	Name	Description
OTHER	Comparison of complications between mastectomies with IBR and mastectomies without IBR	Precocious complications (less than 3 months after surgery) are classified with Clavien's classification : hematoma, seroma, stitches, antibiotics, transfusion. Tardive complications (after 3 months until 1 year) are more specifics : hematoma, seroma, tardive infections, asymmetry, removing of implant, breaking up of implant, skin necrosis, capsular contractures, implant loss, chronic pain.
OTHER	To analyze variations of number of patients eligibles to IBR	Including patients with differents classic risk factors : T3, T4, tobacco, diabetes, overweight and obesity, hypertension, age over 70, thoracic irradiation in the past

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-04-01
• Completion: 2021-06-01
• First posted: 2021-05-17
• Last updated: 2021-05-17

Locations

1 site across 1 country: France