I-PREPARE: International Prospective REgistry on Pre-pectorAl Breast REconstruction
Study Details
Study Description
Brief Summary
This is an international multicenter prospective cohort study aimed at collecting data on breast reconstruction techniques with pre-pectoral implants after mastectomy for breast cancer. The aim of the study is to collect data on the surgical, aesthetic and oncological results, as well as on the quality of life of the patients who will undergo breast reconstruction with a pre-pectoral approach.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
1,236 patients undergoing mastectomy for breast cancer and subsequent pre-pectoral breast reconstruction will be enrolled. Being an observational study, the diagnostic-therapeutic path of the patients will not be modified in any way. Therefore, no risks are anticipated for the patients who will participate in this study. Potential benefits deriving from the study will be for future patients for whom good quality data will be available which can guide the choice of the type of breast reconstruction to be performed, in particular the most appropriate type of technique in the pre-pectoral approach.
Study Design
Outcome Measures
Primary Outcome Measures
- Implant-loss at three months postoperatively [three months postoperatively]
Implant-loss at three months postoperatively defined as the unplanned removal or loss of the implant as a result of infection or other complication
Secondary Outcome Measures
- nfection [three months postoperatively]
Infection defined as minor if oral antibiotic was required, major if surgical revision and/or hospitalisation was necessary;
- Re-admission and re-operation rates [three months postoperatively]
Re-admission and re-operation rates
- Quality of life through [0, 6, 12 and 24 months]
Quality of life through BREASTQ Breast Reconstruction Module questionnaires before and after breast reconstruction at 6 and 12, 24 months
- Early onset complication [three months postoperatively]
Early onset complication at 3 month follow up: seroma, hematoma/bleeding, skin flap or T junction necrosis, nipple necrosis, wound dehiscence, implant malposition (i.e. rotation, displacement etc..), red-breast syndrome
- late-onset complications [6-12-24 months]
seroma, capsular contracture, wrinkling/rippling, implant malposition (i.e. rotation, displacement etc..) implant upper pole visibility, implant loss;
Eligibility Criteria
Criteria
Inclusion Criteria:
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Female patients older than 18 years old
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Signed informed consent form
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Patients undergoing mono or bilateral therapeutic mastectomy
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Patients undergoing pre-pectoral implant-based breast reconstruction with implant or expander with or without mesh
Exclusion Criteria:
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Male patients
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Patients not suitable for surgical treatment
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Patients undergoing subpectoral reconstruction
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Patients undergoing breast reconstruction with autologous tissue.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Oreste Davide Gentilini
- European Breast Cancer Reseach Association of Surgical Trialists
Investigators
- Study Chair: Oreste D Gentilini, Dr, IRCCS San Raffaele
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EUBREAST-11R