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Compares treatment options for Breast Cancer, Breast Neoplasms
Official title Evaluation of Wellbeing and Patient Reported Outcomes After Open vs Robotic Mastectomy With DIEP Reconstruction
ClinicalTrials.gov ID: NCT07230535
What this study is testing
- What it's testing
- Nipple-sparing mastectomy (NSM) preserves the nipple-areolar complex (NAC) and is associated with improved cosmetic outcomes, body image, and patient satisfaction compared with more ablative techniques. Its use has expanded in both therapeutic and risk-reducing settings, including ductal carcinoma in situ (DCIS) and early-stage invasive breast cancer, where the NAC is not clinically or radiologically involved.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Women aged 18 years and older
- Candidates who have already been selected to undergo mastectomy (of any kind) and immediate DIEP reconstruction by the breast MDT for the following...
- Genetic mutation carriers undergoing risk-reducing mastectomy.
- Ductal carcinoma in situ (DCIS) requiring mastectomy.
- Early invasive breast cancer requiring mastectomy.
You likely can't join if
- Advanced breast cancer with skin involvement for Nipple Sparing Mastectomy Arms
- Nipple involvement for Nipple Sparing Mastectomy Arms.
- Prior chest wall radiation therapy
- Pregnancy
- Lactation
- Patients with insufficient English to sign an informed consent (i.e. interpreter required).
See the full eligibility criteria
- Women aged 18 years and older
- Candidates who have already been selected to undergo mastectomy (of any kind) and immediate DIEP reconstruction by the breast MDT for the following indications:
- Genetic mutation carriers undergoing risk-reducing mastectomy.
- Ductal carcinoma in situ (DCIS) requiring mastectomy.
- Early invasive breast cancer requiring mastectomy.
- For those considered for Nipple Sparing Mastectomy randomisation arms the tumour must not have skin involvement and no evidence of invasive disease within 1cm of skin, nipple or Pec major muscle (as proven on MRI).
- Candidates for immediate breast reconstruction with DIEP reconstruction
- Fluent in English
- Fit for general anaesthetic
- Signed informed consent form
- Advanced breast cancer with skin involvement for Nipple Sparing Mastectomy Arms
- Nipple involvement for Nipple Sparing Mastectomy Arms.
- Prior chest wall radiation therapy
- Pregnancy
- Lactation
- Patients with insufficient English to sign an informed consent (i.e. interpreter required).
The study team makes the final eligibility decision.
Where it's taking place
- Beaumont, Ireland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beaumont, Ireland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.