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

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

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Breast Reconstruction
• Intervention / Treatment: Other: Comparison of complications between mastectomies with IBR and mastectomies without IBR; Other: To analyze variations of number of patients eligibles to IBR

• Study Type: Observational
• Enrollment (Anticipated): 215

Contacts and Locations

• Study Contact: Name: Marion CORTET, MD; Phone Number: +33 4 27 85 40 78; Email: marion.cortet@chu-lyon.fr

Study Locations

• France
  • Lyon, France, 69004
    • Recruiting
    • Hôpital de la Croix-Rousse
    • Contact: Marion CORTET, MD; Phone Number: +33 4 27 85 40 78; Email: marion.cortet@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	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
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	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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2021
• Primary Completion (ACTUAL): April 1, 2021
• Study Completion (ANTICIPATED): June 1, 2021

Study Registration Dates

• First Submitted: May 11, 2021
• First Submitted That Met QC Criteria: May 11, 2021
• First Posted (ACTUAL): May 17, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 17, 2021
• Last Update Submitted That Met QC Criteria: May 11, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Breast cancer; Mastectomy; Immediate Breast Reconstruction (IBR)
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 69HCL21_0145

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No