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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C031208', 'term': 'specific substance maruyama'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 104}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-11-13', 'studyFirstSubmitQcDate': '2025-11-14', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint of this study is the difference in patient-reported outcomes at 12 months postoperatively.', 'timeFrame': 'Up to 12 months post operative', 'description': 'Difference in patient-reported outcomes at 12 months postoperatively, assessed using the BREAST-Q Reconstruction Module'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer, Breast Neoplasms', 'Breast Reconstruction', 'DIEP Flap Breast Reconstruction', 'Robotic Surgery']}, 'referencesModule': {'references': [{'pmid': '34597010', 'type': 'BACKGROUND', 'citation': 'Toesca A, Sangalli C, Maisonneuve P, Massari G, Girardi A, Baker JL, Lissidini G, Invento A, Farante G, Corso G, Rietjens M, Peradze N, Gottardi A, Magnoni F, Bottiglieri L, Lazzeroni M, Montagna E, Labo P, Orecchia R, Galimberti V, Intra M, Sacchini V, Veronesi P. A Randomized Trial of Robotic Mastectomy Versus Open Surgery in Women With Breast Cancer or BrCA Mutation. Ann Surg. 2022 Jul 1;276(1):11-19. doi: 10.1097/SLA.0000000000004969. Epub 2021 Jun 9.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nRobotic-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.\n\nDespite 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.\n\nSkin-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.\n\nThis 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.\n\nThis 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.', 'detailedDescription': 'The study will be a prospective, single blinded (assessors), randomised controlled trial.\n\nThere will be 3 groups:\n\nArm 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 18 years and older\n* Candidates who have already been selected to undergo mastectomy (of any kind) and immediate DIEP reconstruction by the breast MDT for the following indications:\n\n 1. Genetic mutation carriers undergoing risk-reducing mastectomy.\n 2. Ductal carcinoma in situ (DCIS) requiring mastectomy.\n 3. Early invasive breast cancer requiring mastectomy.\n 4. For those considered for Nipple Sparing Mastectomy randomisation arms the tumour must not have skin involvement and no evidence of invasive disease within 1cm of skin, nipple or Pec major muscle (as proven on MRI).\n* Candidates for immediate breast reconstruction with DIEP reconstruction\n* Fluent in English\n* Fit for general anaesthetic\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Advanced breast cancer with skin involvement for Nipple Sparing Mastectomy Arms\n* Nipple involvement for Nipple Sparing Mastectomy Arms.\n* Prior chest wall radiation therapy\n* Pregnancy\n* Lactation\n* Patients with insufficient English to sign an informed consent (i.e. interpreter required).'}, 'identificationModule': {'nctId': 'NCT07230535', 'acronym': 'REBORN', 'briefTitle': 'Evaluation of Wellbeing and Patient Reported Outcomes After Open vs Robotic Mastectomy With DIEP Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Beaumont Hospital'}, 'officialTitle': 'A Randomised Control Trial Evaluating Well Being and Patient Reported Outcomes After Open vs Robotic Single-port Nipple Sparing Mastectomy With DIEP Reconstruction', 'orgStudyIdInfo': {'id': '25/56'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Standard of care Standard NSM with DIEP reconstruction', 'interventionNames': ['Procedure: Standard nipple sparing mastectomy with DIEP reconstruction']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Arm A: Single-port robotic nipple sparing mastectomy (SpRNSM) with DIEP reconstruction', 'interventionNames': ['Procedure: Single-port robotic nipple sparing mastectomy (SpRNSM) with DIEP reconstruction']}, {'type': 'OTHER', 'label': 'Skin-sparing mastectomy (SSM) with DIEP reconstruction', 'description': 'Skin-sparing mastectomy (SSM) with DIEP reconstruction', 'interventionNames': ['Procedure: Skin-sparing mastectomy (SSM) with DIEP reconstruction']}], 'interventions': [{'name': 'Single-port robotic nipple sparing mastectomy (SpRNSM) with DIEP reconstruction', 'type': 'PROCEDURE', 'description': 'Single-port robotic nipple sparing mastectomy (SpRNSM) with DIEP reconstruction', 'armGroupLabels': ['Intervention']}, {'name': 'Standard nipple sparing mastectomy with DIEP reconstruction', 'type': 'PROCEDURE', 'description': 'Standard of care - standard NSM with DIEP reconstruction', 'armGroupLabels': ['Control']}, {'name': 'Skin-sparing mastectomy (SSM) with DIEP reconstruction', 'type': 'PROCEDURE', 'description': 'Skin-sparing mastectomy (SSM) with DIEP reconstruction', 'armGroupLabels': ['Skin-sparing mastectomy (SSM) with DIEP reconstruction']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Trudi Nelson Roche', 'role': 'CONTACT', 'email': 'troche@rcsi.ie', 'phone': '003531'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'description': 'Study protocol and anonymised data related to the results will be made available through peer review publication.', 'accessCriteria': 'Peer review publications'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beaumont Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Arnold Hill', 'investigatorAffiliation': 'Beaumont Hospital'}}}}