Immediate Breast Reconstruction's Increasing
IBRI
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
1 other identifier
observational
215
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedFirst Submitted
Initial submission to the registry
May 11, 2021
CompletedFirst Posted
Study publicly available on registry
May 17, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedMay 17, 2021
March 1, 2021
3 months
May 11, 2021
May 11, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Global complications's rates in 2 groups (percentage)
Comparison of complications between mastectomies with IBR and mastectomies without IBR
During first year after surgery
Study Arms (2)
Mastectomies with IBR
Every women\>18 years who underwent mastectomies followed by IBR (prothesis, latissimus dorsi flap, lipofeeling, isolated or combined) for breast cancer in Hôpital de la Croix-Rousse between January 2016 and January 2020
Mastectomies without IBR
Every women\>18 years who underwent mastectomies for breast cancer followed by delayed reconstructions (prothesis, latissimus dorsi flap, lipofeeling, isolated or combined) or no reconstructions between January 2016 and January 2020 in Hôpital de la Croix-Rousse
Interventions
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.
Including patients with differents classic risk factors : T3, T4, tobacco, diabetes, overweight and obesity, hypertension, age over 70, thoracic irradiation in the past
Eligibility Criteria
Female patients aged 18 or more, who have had a mastectomy for breast cancer in Croix-Rousse's hospital in Lyon, between 1st of January 2016 and 31st of December 2020
You may qualify if:
- Over 18 years
- Breast cancer
- Mastectomy
- Hopital de la Croix-Rousse
- January 2016 and January 2020
You may not qualify if:
- Prophylactic mastectomy
- Male gender
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital de la Croix-Rousse
Lyon, 69004, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2021
First Posted
May 17, 2021
Study Start
January 1, 2021
Primary Completion
April 1, 2021
Study Completion
June 1, 2021
Last Updated
May 17, 2021
Record last verified: 2021-03