Endoscopy/Robotic Assisted Nipple Skin Sparing Mastectomy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorAlejandra García-Novoa

About this trial

Non-inferiority study of video-assisted (endoscopic or robotic) skin- and nipple-sparing mastectomy compared to open mastectomy. The feasibility of the technique, oncological safety and cosmetic results will be studied.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women who require a mastectomy and who do not require skin reduction or resection are included. Women with both breast cancer and those at high risk for breast cancer are included.

Disqualifiers

Sarcomas of the breast.

Benign breast tumors.

Prepectoral reconstruction with expansion.

Impossibility to preserve the skin.

Trial population

Patient with breast cancer or high risk for breast cancer who need a mastectomy. The mastectomy will be skin and nipple preserving and will be performed with endoscopic assistance

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Video assisted mastectomy

    Other intervention

    Nipple Skin sparing mastectomy assisted by endoscopic or robotic

Treatment groups

126 Participants
are divided into 1 treatment group
Group A: Video assisted mastectomy1 intervention

Trial outcomes

Primary outcomes

1

Implant Loss

Safety of the reconstruction technique, calculated by the number of implants lost

Time frame
First year after surgery

Secondary outcomes

1

local relapse

evaluate oncological safety in terms of local relapses

Time frame
first 5 years
2

Glandular residual tissue

Residual glandular tissue after endoscopic mastectomy identified by magnetic resonance imaging one year after the intervention

Time frame
first year
3

Suvival

Overall survival

Time frame
5 years

Other outcomes

Sponsors and contacts

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

Alejandra García-Novoa

Lead sponsor

University Hospital A Coruña

Sponsor institution