A Randomised Controlled Trial Comparing Wellbeing and Patient-Reported Outcomes After Robotic Single-Port Versus Open Nipple-Sparing Mastectomy with DIEP Reconstruction

What this Trial Is About

Researchers are evaluating the differences in patient-reported outcomes between robotic-assisted and conventional open nipple-sparing mastectomy (NSM) in women undergoing immediate breast reconstruction. This trial focuses on women with breast cancer or those at high risk, including genetic mutation carriers and those with ductal carcinoma in situ or early invasive breast cancer. The study aims to determine if the minimally invasive robotic approach offers better cosmetic results, body image, and satisfaction compared to the traditional open surgery. Both implant-based and autologous DIEP flap reconstructions are included to enhance the relevance of the findings. Participants will be randomly assigned to one of two treatment groups within separate reconstruction cohorts. One group receives robotic-assisted NSM using a single-port robotic system through a single axillary incision, performed at a central surgical hub. The other group undergoes standard open NSM through a conventional incision at either local or central sites depending on reconstruction needs. Immediate breast reconstruction follows the assigned NSM technique, either implant-based or DIEP flap. This multicenter study uses a hub-and-spoke model to provide access to robotic surgery while maintaining oncological safety. During the study, participants will be followed for up to 12 months postoperatively. Researchers will collect patient-reported outcomes using validated tools such as the Breast-Q, Hopwood Body Image Scale, and Aesthetic Item Scale to assess satisfaction, body image, and aesthetic results. Blinded assessors will evaluate aesthetic outcomes to reduce bias. Eligibility is carefully determined by clinical and radiological criteria to ensure appropriate candidates for NSM. The study also monitors safety and recovery, aiming to guide future patient care and surgical decision-making in breast cancer treatment.

Evaluation of Wellbeing and Patient Reported Outcomes After Open vs Robotic Mastectomy With DIEP Reconstruction