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NCT04888351 Clinical Trial

Immediate Breast Reconstruction's Increasing

Breast Cancer Clinical Trial

— IBRI  

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04888351
Other study ID # 69HCL21_0145
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date June 2021

Study information
Verified date March 2021
Source Hospices Civils de Lyon
Contact Marion CORTET, MD
Phone 4 27 85 40 78
Email marion.cortet@chu-lyon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 215
Est. completion date June 2021
Est. primary completion date April 1, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Over 18 years - Breast cancer - Mastectomy - Hopital de la Croix-Rousse - January 2016 and January 2020 Exclusion Criteria: - Prophylactic mastectomy - Male gender

Study Design

Related Conditions & MeSH terms

Intervention

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.
• 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

Locations
Country Name City State
France Hôpital de la Croix-Rousse Lyon

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Global complications's rates in 2 groups (percentage) Comparison of complications between mastectomies with IBR and mastectomies without IBR During first year after surgery
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