NCT Number: NCT05817175
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.
Interested in participating?
Request Info18 year and older
Female
Observational
Univesidad de Buenos Aires, Buenos Aires, Argentina
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
to prospectively evaluate the utilization of the pre-pectoral approach, and evaluate oncological and aesthetic outcomes related to each type of surgical technique and the use of postmastectomy radiation therapy
Time frame: three months postoperatively
Rate of implant-loss at three months postoperatively defined as the unplanned removal or loss of the implant as a result of infection or other complication
Time frame: three months postoperatively
Rate of infection defined as minor if oral antibiotic was required, major if surgical revision and/or hospitalisation was necessary;
Time frame: three months postoperatively
Rate of re-admission and re-operation
Time frame: 0, 6, 12 and 24 months
Patient's satisfaction and quaity of life measured through BREASTQ (Breast Reconstruction Module Questionnaire)
Time frame: 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
Time frame: 6-12-24 months
seroma, capsular contracture, wrinkling/rippling, implant malposition (i.e. rotation, displacement etc..) implant upper pole visibility, implant loss;
Contact information is provided by the study sponsor or research team.
IRCCS San Raffaele
Other
Acronym: I-PREPARE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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