NCT07236359

Evaluation of Well Being and Patient Reported Outcomes After Robotic Single-port Nipple Sparing Mastectomy and Implant Reconstruction

A Randomised Control Trial Evaluating Well Being and Patient Reported Outcomes After Robotic Single-port Nipple Sparing Mastectomy and Implant Reconstruction

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Beaumont Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being carried out to better understand how different types of mastectomy surgeries affect women's recovery, satisfaction, and overall well-being after breast cancer surgery and reconstruction. There are different ways to perform a mastectomy. In some patients, a nipple-sparing mastectomy may be suitable, where the nipple and surrounding breast skin are preserved. This approach allows for immediate breast reconstruction with an implant, which is placed at the same time as the mastectomy to restore the breast shape. A newer technique called robotic single-port nipple-sparing mastectomy uses advanced robotic technology to remove breast tissue through a small hidden incision at the side of the chest. This method may reduce scarring, pain, and recovery time, while preserving the appearance and sensation of the breast. However, while early studies suggest this technique is safe and effective, more evidence is needed to compare it directly with standard surgeries. This study will compare: * Robotic nipple-sparing mastectomy * Standard (open) nipple-sparing mastectomy We will assess patient satisfaction, body image, physical and emotional well-being, and surgical outcomes over 12 months following surgery. By taking part, you are helping researchers evaluate whether robotic and nipple-sparing approaches offer measurable benefits to patients. Taking part in this study will not affect your surgery or the care you receive. You will be given the best treatment available based on your individual medical needs, whether or not you decide to participate in the research.

Conditions

• Breast Reconstruction
• Breast Cancer
• Hereditary Breast/Ovarian Cancer (brca1, brca2)
• Robotic Surgery

Interventions

Type	Name	Description
PROCEDURE	Intervention	Single-port robotic nipple-sparing mastectomy with immediately implant based reconstruction.
PROCEDURE	Standard open nipple sparing mastectomy with immediate implant-based reconstruction	Standard open nipple sparing mastectomy with immediate implant-based reconstruction

Timeline

• Start date: 2025-12-31
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2025-11-19
• Last updated: 2025-11-19