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NCT Number: NCT06774352

Prosthetic Breast Reconstruction After Mastectomy

Breast cancer represents a disabling diagnosis for women, and the related destructive surgical intervention of mastectomy inevitably affects their social, relational and working life. The primary aim of post-oncological breast reconstruction is to restore volume, shape and projection as similar as possible to the contralateral breast, in unilateral mastectomies and between the two reconstructed breasts, in bilateral mastectomies, avoiding the patient the need to resort to uncomfortable and unsightly external prostheses.

The study in question has a purely observational and non-interventional nature, in order to evaluate whether today the traditional EXP-IMPL prosthetic reconstructive technique represents an obsolete option or whether it can still be considered a valid alternative in clinical, anthropometric and patient satisfaction terms

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Key information

Conditions

Breast Reconstruction

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

IRCCS AOU di Bologna Policlinico di Sant'Orsola

Bologna, 40138, Italy

Location status: Recruiting

Location contact

Marco Pignatti, MD

CONTACT

[email protected]

051 2143614 ext. +39

Marco Pignatti, MD

PRINCIPAL_INVESTIGATOR

About this study

The primary aim of post-oncological breast reconstruction is to restore volume, shape and projection as similar as possible to the contralateral breast, in unilateral mastectomies and between the two reconstructed breasts, in bilateral mastectomies, avoiding the patient the need to resort to uncomfortable and unexpectedly external prostheses.

The study in question has a purely observational and non-interventional nature, in order to evaluate whether today the traditional EXP-IMPL prosthetic reconstructive technique represents an obsolete option or whether it can still be considered a valid alternative in clinical, anthropometric and patient satisfaction terms. In order to evaluate outcomes in prosthetic breast reconstructions immediate (DTI - Direct to Implant) and in two surgical stages (EXP-IMPL - expander/prosthesis), after mastectomy, the aforementioned data will be subjected to appropriate statistical analysis

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Sex F
  • Patients undergoing mastectomy (R-m, SS-m, NSS-m)
  • Age 18 - 70
  • Prosthetic breast reconstruction (DTI or EXP-IMPL)
  • Written informed consent

Exclusion criteria

  • Autologous breast reconstruction

Treatment and study plan

Primary outcomes

  1. Technical Success

    Time frame: From the first patient entrolled, up to the 200th patient, an average of 2 years

    Technical Success is defined by number of reinterveions, major complication and the necessity to change approach.

Secondary outcomes

  1. Patient satisfaction

    Time frame: From the first patient enrolled, up to the 200th. An average of 2 years

    Satisfaction is measured by specific Q-Breast questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Marco Pignatti, MD

CONTACT

[email protected]

+39 051 2143614

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

Prosthetic Breast Reconstruction After Mastectomy: Comparison of Clinical, Anthropometric and Patient Satisfaction Parameters

Acronym: BrREC2020

Important dates

Study start
2011
Primary completion
2027
Study completion
2027
First posted
Jan 14, 2025
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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