International Prospective REgistry on Pre-pectorAl Breast REconstruction (I-PREPARE)

September 27, 2023 updated by: Oreste Davide Gentilini
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

1236

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients who are candidates for implant-based reconstruction should be informed about the possible participation to this clinical study. The inclusion and exclusion criteria are verified by the investigator and an informed consent is obtained from the patient.

The therapeutic pattern should be followed according to institutional and national standards. Since this is a non-interventional trial, the study sites do not deviate from their own study protocol at any timepoint.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with Implant-loss at three months postoperatively
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
three months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with Infection
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;
three months postoperatively
Number of patients with re-admission and re-operation
Time Frame: three months postoperatively
Rate of re-admission and re-operation
three months postoperatively
Evaluation of Quality of life
Time Frame: 0, 6, 12 and 24 months
Patient's satisfaction and quaity of life measured through BREASTQ (Breast Reconstruction Module Questionnaire)
0, 6, 12 and 24 months
Number of Early onset complication
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
three months postoperatively
Number of late-onset complications
Time Frame: 6-12-24 months
seroma, capsular contracture, wrinkling/rippling, implant malposition (i.e. rotation, displacement etc..) implant upper pole visibility, implant loss;
6-12-24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oreste Davide Gentilini

Collaborators

European Breast Cancer Reseach Association of Surgical Trialists

Investigators

  • Study Chair: Oreste D Gentilini, Dr, IRCCS San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 10, 2024

Primary Completion (Estimated)

September 10, 2027

Study Completion (Estimated)

September 10, 2027

Study Registration Dates

First Submitted

April 4, 2023

First Submitted That Met QC Criteria

April 4, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EUBREAST-11R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on pre-pectoral breast reconstruction

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe