International Prospective REgistry on Pre-pectorAl Breast REconstruction

Breast Cancer Clinical Trial

— I-PREPARE  

Official title:

International Prospective REgistry on Pre-pectorAl Breast REconstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05817175
• Other study ID #: EUBREAST-11R
• Status: Recruiting
• Start date: October 16, 2023
• Est. completion date: September 10, 2027

Study information

• Verified date: May 2024
• Source: IRCCS San Raffaele
• Contact: Oreste D Gentilini, Dr
• Phone: +390226431
• Email: gentilini[@]eubreast.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1236
• Est. completion date: September 10, 2027
• Est. primary completion date: September 10, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female patients older than 18 years old
• Signed informed consent form
• Patients undergoing mono or bilateral therapeutic mastectomy
• Patients undergoing pre-pectoral implant-based breast reconstruction with implant or expander with or without mesh

Exclusion Criteria:

• Male patients
• Patients not suitable for surgical treatment
• Patients undergoing subpectoral reconstruction
• Patients undergoing breast reconstruction with autologous tissue.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• pre-pectoral breast reconstruction
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

Locations

Country	Name	City	State
Argentina	Univesidad de Buenos Aires	Buenos Aires
Egypt	Mansoura Insurance	Mansoura
Egypt	Mansoura Oncology	Mansoura
Greece	National ans Kapodistrian University of Athens	Athens
Italy	Ospedale San Raffaele	Milano	MI
Italy	Fondazione Policlinico Universitario Agostino Gemelli	Roma	RM
Poland	University Hospital of Karol Marcinkowski	Zielona Góra
Romania	Prof. Dr. Ion Chiricuta Institute of Oncology	Cluj-Napoca
Spain	Hospital del Mar	Barcelona
Turkey	Marmara University School of medicine	Istanbul
United Kingdom	University Hospitals of Leicester	Leicester

Sponsors (2)

Lead Sponsor	Collaborator
IRCCS San Raffaele	EUBREAST ETS

Countries where clinical trial is conducted

Argentina,  Egypt,  Greece,  Italy,  Poland,  Romania,  Spain,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with Implant-loss at 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	three months postoperatively
Secondary	Number of patients with Infection	Rate of infection defined as minor if oral antibiotic was required, major if surgical revision and/or hospitalisation was necessary;	three months postoperatively
Secondary	Number of patients with re-admission and re-operation	Rate of re-admission and re-operation	three months postoperatively
Secondary	Evaluation of Quality of life	Patient's satisfaction and quaity of life measured through BREASTQ (Breast Reconstruction Module Questionnaire)	0, 6, 12 and 24 months
Secondary	Number of Early onset complication	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	three months postoperatively
Secondary	Number of late-onset complications	seroma, capsular contracture, wrinkling/rippling, implant malposition (i.e. rotation, displacement etc..) implant upper pole visibility, implant loss;	6-12-24 months