Ignite Creation Date:
2025-12-24 @ 10:18 PM
Ignite Modification Date:
2025-12-25 @ 7:51 PM
Study NCT ID:
NCT07230535
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-17
First Post:
2025-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Wellbeing and Patient Reported Outcomes After Open vs Robotic Mastectomy With DIEP Reconstruction
Sponsor:
Beaumont Hospital
Organization:
Study Overview
Official Title:
A Randomised Control Trial Evaluating Well Being and Patient Reported Outcomes After Open vs Robotic Single-port Nipple Sparing Mastectomy With DIEP Reconstruction
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REBORN
Brief Summary:
Nipple-sparing mastectomy (NSM) preserves the nipple-areolar complex (NAC) and can improve cosmetic outcomes, body image and patient satisfaction. It is increasingly used for risk-reducing surgery, ductal carcinoma in situ (DCIS), and early breast cancer where the NAC is not involved. Studies indicate that NSM is oncologically safe in appropriately selected patients, although careful surgical and pathological assessment is required to minimise the risk of residual disease.
Robotic-assisted NSM has emerged as a minimally invasive alternative offering enhanced visualisation, greater precision, and reduced surgeon fatigue. The Da Vinci single-port (SP) system enables NSM through a single axillary incision, potentially reducing postoperative pain and visible scarring while maintaining oncologic safety. Early series, including those by Toesca, Farr and Sarfati, demonstrate feasibility and suggest comparable outcomes to conventional NSM with possible aesthetic advantages.
Despite broader adoption of NSM-both standard and robotic-there is limited high-quality evidence evaluating patient-reported outcomes (PROs). Tools such as the Breast-Q, Hopwood Body Image Scale, and Aesthetic Item Scale (AIS) are validated for assessing satisfaction, psychological well-being and aesthetic outcomes, yet prospective randomised data comparing SP robotic NSM, standard NSM and skin-sparing mastectomy (SSM) remain scarce.
Skin-sparing mastectomy (SSM), which removes the NAC while preserving the skin envelope, is an established oncologic technique and provides an important comparator to determine whether NAC preservation yields measurable benefits in PROs.
This trial evaluates these surgical approaches exclusively in patients undergoing autologous DIEP flap reconstruction, which provides superior long-term satisfaction and physical well-being compared with implant-based methods. Restricting reconstruction to DIEP flaps reduces heterogeneity and allows the trial to isolate differences attributable to the mastectomy technique itself.
This randomised controlled trial will compare SP robotic NSM, standard NSM and SSM using validated PRO measures at multiple postoperative time points. Findings will help determine the relative value of robotic technology and NAC preservation in the context of autologous reconstruction, informing surgical decision-making and future service development.
Robotic-assisted NSM has emerged as a minimally invasive alternative offering enhanced visualisation, greater precision, and reduced surgeon fatigue. The Da Vinci single-port (SP) system enables NSM through a single axillary incision, potentially reducing postoperative pain and visible scarring while maintaining oncologic safety. Early series, including those by Toesca, Farr and Sarfati, demonstrate feasibility and suggest comparable outcomes to conventional NSM with possible aesthetic advantages.
Despite broader adoption of NSM-both standard and robotic-there is limited high-quality evidence evaluating patient-reported outcomes (PROs). Tools such as the Breast-Q, Hopwood Body Image Scale, and Aesthetic Item Scale (AIS) are validated for assessing satisfaction, psychological well-being and aesthetic outcomes, yet prospective randomised data comparing SP robotic NSM, standard NSM and skin-sparing mastectomy (SSM) remain scarce.
Skin-sparing mastectomy (SSM), which removes the NAC while preserving the skin envelope, is an established oncologic technique and provides an important comparator to determine whether NAC preservation yields measurable benefits in PROs.
This trial evaluates these surgical approaches exclusively in patients undergoing autologous DIEP flap reconstruction, which provides superior long-term satisfaction and physical well-being compared with implant-based methods. Restricting reconstruction to DIEP flaps reduces heterogeneity and allows the trial to isolate differences attributable to the mastectomy technique itself.
This randomised controlled trial will compare SP robotic NSM, standard NSM and SSM using validated PRO measures at multiple postoperative time points. Findings will help determine the relative value of robotic technology and NAC preservation in the context of autologous reconstruction, informing surgical decision-making and future service development.
Detailed Description:
The study will be a prospective, single blinded (assessors), randomised controlled trial.
There will be 3 groups:
Arm A: Single-port robotic nipple sparing mastectomy (SpRNSM) with DIEP reconstruction Arm B: Standard NSM with DIEP reconstruction Arm C: Skin-sparing mastectomy (SSM) with DIEP reconstruction (Exploratory Arm - not included in sample size calculation) All patients eligible for mastectomy will be considered suitable for inclusion. Patients who are eligible for nipple-sparing mastectomy (i.e. have tumours not involving skin and are \>1cm from the nipple areolar complex and Pec major muscles) will be randomised to either receive a SpRNSM or Standard Open approach NSM via a lateral radial incision. Patients who are not eligible for a NSM will be assigned to the SSM control arm (Arm C) Blinding will be performed of the outcome assessors (e.g. for aesthetic evaluation and Breast-Q analysis) blinded to randomisation.
There will be 3 groups:
Arm A: Single-port robotic nipple sparing mastectomy (SpRNSM) with DIEP reconstruction Arm B: Standard NSM with DIEP reconstruction Arm C: Skin-sparing mastectomy (SSM) with DIEP reconstruction (Exploratory Arm - not included in sample size calculation) All patients eligible for mastectomy will be considered suitable for inclusion. Patients who are eligible for nipple-sparing mastectomy (i.e. have tumours not involving skin and are \>1cm from the nipple areolar complex and Pec major muscles) will be randomised to either receive a SpRNSM or Standard Open approach NSM via a lateral radial incision. Patients who are not eligible for a NSM will be assigned to the SSM control arm (Arm C) Blinding will be performed of the outcome assessors (e.g. for aesthetic evaluation and Breast-Q analysis) blinded to randomisation.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: