Health TrialsbyHealthPanel

Robotic Nipple Sparing Mastectomy with Immediate Reconstruction

ConditionsBreast CancerDCISBRCA Mutation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorEuropean Institute of Oncology

About this trial

Aim of this trial is to verify whether the patients' quality of life can be improved by a less invasive surgical procedure and whether the use of robotic technique for nipple-sparing mastectomy associated to prepectoral direct implant procedure can impact on perioperative and postoperative period and on oncologic outcome.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Candidates to nipple-sparing mastectomy and immediate breast reconstruction for invasive breast cancer, ductal carcinoma in situ (DCIS), BReast CAncer gene (BRCA) mutation carriers

Any age

Negative preoperative assessment of nipple-areola complex

Absence of skin involvement

Disqualifiers

Previous thoracic radiation therapy for any reason

Inflammatory Breast Cancer

Pregnancy

Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study.

Trial design

Design model

Single group

Treatments tested in this trial

  • Robotic Nipple-Sparing Mastectomy

    Other intervention

    Patient will undergo to nipple sparing mastectomy and breast reconstruction, conducted using robot

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Robotic Nipple-Sparing MastectomyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Surgery time

Evaluation of average length of robotic procedure

Time frame
1 month
2

Post operative complications

Number of post operative complications (pain, skin or nipple-areola injury or necrosis or infection, hematoma, seroma)

Time frame
1 month
3

Post operative pain

Evaluation of postoperative pain by White and Song scale (minimum value: 0, maximum value: 2 - lower scores indicate higher pain)

Time frame
1 month
4

Length of stay of patients

Evaluation of average length of stay of patients

Time frame
1 month

Secondary outcomes

1

Cumulative incidence of local recurrence

Number of local recurrence

Time frame
5 years
2

Cumulative incidence of axillary recurrences

Number of axillary recurrences

Time frame
5 years
3

Cumulative incidence of distant recurrences

Number of distant recurrences

Time frame
5 years
4

Disease-free survival (DFS)

Interval from surgery to recurrence of disease

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

European Institute of Oncology

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: