An observational study in Breast Reconstruction and Breast Cancer, sponsored by Hospices Civils de Lyon. Status unknown at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-17.
Sponsored by Hospices Civils de Lyon · Observational
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
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 215 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
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
Other: Comparison of complications between mastectomies with IBR and mastectomies without IBR · Other: To analyze variations of number of patients eligibles to 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
Other: Comparison of complications between mastectomies with IBR and mastectomies without IBR · Other: To analyze variations of number of patients eligibles to 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.
Including patients with differents classic risk factors : T3, T4, tobacco, diabetes, overweight and obesity, hypertension, age over 70, thoracic irradiation in the past
Global complications's rates in 2 groups (percentage)
Comparison of complications between mastectomies with IBR and mastectomies without IBR
Time frame: During first year after surgery
This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hospices Civils de Lyon