Clinical trial · Observational
A Comparative Study of Nipple Sensation Preservation After Nipple-Sparing Mastectomy With Conventional, Endoscopic, Robotic Techniques
NIPSENSE - A Comparative Study of Nipple and Skin Sensation Preservation After Nipple-Sparing Mastectomy With Conventional, Endoscopic, and Robotic Techniques
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this comparative study is to learn how different surgical methods affect nipple and skin sensation after nipple-sparing mastectomy (NSM). The study will compare three types of NSM: conventional, endoscopic, and robotic. The main question it aims to answer is: How much nipple sensation do participants keep after each type of surgery? Researchers will also look at surgery-related complications, patient-reported outcomes like body image and quality of life, and tissue analysis to see if there is a link between nerve structures and sensation. Participants will: Have NSM using one of the three surgical approaches Receive breast reconstruction with an implant during the same surgery Complete nipple sensation tests before and at 1, 3, and 6 months after surgery Answer surveys about their quality of life and body image Provide surgical tissue for analysis (as part of the planned procedure)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sensation Disorder | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nipple Sensation Assessment | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Conventional Nipple-Sparing Mastectomy (C-NSM)
- description
- Participants in this group will undergo a standard open nipple-sparing mastectomy using traditional surgical instruments. The procedure is performed through a visible incision on the breast, while preserving the nipple and surrounding skin. An implant is placed for immediate reconstruction.
- interventionNames
- Diagnostic Test: Nipple Sensation Assessment
- label
- Endoscopic Nipple-Sparing Mastectomy (E-NSM)
- description
- This group will receive a minimally invasive nipple-sparing mastectomy using an endoscopic technique. The breast tissue is removed through a small incision in the armpit using a camera and specialized instruments. An implant is placed during the same surgery
- interventionNames
- Diagnostic Test: Nipple Sensation Assessment
- label
- Robotic Nipple-Sparing Mastectomy (R-NSM)
- description
- Participants in this group will undergo a robotic-assisted nipple-sparing mastectomy. The surgery is performed using a robotic surgical system through a small armpit incision, offering enhanced precision and visualization. Immediate implant reconstruction is also performed.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients aged ≥18 years. * Diagnosed with early-stage breast cancer or deemed at high risk for breast cancer (eg. BRCA1-2 mutations). * Candidates for Nipple-Sparing Mastectomy (NSM). * Able to provide informed consent. * No contraindications for surgery based on physical examination and preoperative assessment. * Signed the consent forms and willing to participate in all scheduled follow-up assessments. Exclusion Criteria: * Previous breast surgery. * History of radiation therapy to the chest/breast area. * Active or non-controlled diabetes mellitus. * Neuropathies causing potentially altered skin sensation. * Nipple involvement by cancer, clinical or reported intra-operatively via frozen section analysis (the procedure will be converted to SSM).
References
Publications (32)
- RESULTMoortgat P, Anthonissen M, Van Daele U, Meirte J, Vanhullebusch T, Maertens K. Objective Assessment Techniques: Physiological Parameters in Scar Assessment. 2020 Dec 8. In: Teot L, Mustoe TA, Middelkoop E, Gauglitz GG, editors. Textbook on Scar Management: State of the Art Management and Emerging Technologies [Internet]. Cham (CH): Springer; 2020. Chapter 18. Available from http://www.ncbi.nlm.nih.gov/books/NBK586121/ PMID 36351153
- RESULTKostidou E, Schmelz M, Hasemaki N, Kokotis P. Objective Methods for Breast Sensibility Testing. Plast Reconstr Surg. 2019 Feb;143(2):398-404. doi: 10.1097/PRS.0000000000005200. PMID 30688881
- RESULTTevlin R, Brazio P, Tran N, Nguyen D. Immediate targeted nipple-areolar complex re-innervation: Improving outcomes in immediate autologous breast reconstruction. J Plast Reconstr Aesthet Surg. 2021 Jul;74(7):1503-1507. doi: 10.1016/j.bjps.2020.11.021. Epub 2020 Dec 3. PMID 33341386
- RESULTPrado A, Andrades P, Benitez S, Parada F. Areola-nipple perception threshold to faradic electricity: a new measure of sensibility of the breasts. Aesthetic Plast Surg. 2008 Sep;32(5):748-52. doi: 10.1007/s00266-008-9148-4. Epub 2008 Apr 29. PMID 18443851
- RESULTWeinstein S. Fifty years of somatosensory research: from the Semmes-Weinstein monofilaments to the Weinstein Enhanced Sensory Test. J Hand Ther. 1993 Jan-Mar;6(1):11-22; discussion 50. PMID 8343870
- RESULTSantanelli F, Paolini G, Bittarelli D, Nofroni I. Computer-assisted evaluation of nipple-areola complex sensibility in macromastia and following superolateral pedicle reduction mammaplasty: a statistical analysis. Plast Reconstr Surg. 2007 May;119(6):1679-1683. doi: 10.1097/01.prs.0000258828.84107.59. PMID 17440341
- RESULTvan Verschuer VM, Mureau MA, Gopie JP, Vos EL, Verhoef C, Menke-Pluijmers MB, Koppert LB. Patient Satisfaction and Nipple-Areola Sensitivity After Bilateral Prophylactic Mastectomy and Immediate Implant Breast Reconstruction in a High Breast Cancer Risk Population: Nipple-Sparing Mastectomy Versus Skin-Sparing Mastectomy. Ann Plast Surg. 2016 Aug;77(2):145-52. doi: 10.1097/SAP.0000000000000366.