Evidence map›Paper›PMID 42463607›Full record

Trial reportAnnals of surgical oncology2026

A Prospective, Multicenter Randomized Controlled Trial (RCT) of the da Vinci SP

Katherine Kopkash, Mara Piltin, James Jakub, Sara Javid, Meghan R Flanagan, Rebecca Aft, Akiko Chiba, Alysandra Lal, Ari D Brooks, Farin Amersi and 6 more

Abstract readMulticenter StudyRandomized Controlled TrialComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of surgical oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Katherine KopkashDepartment of Surgery, Endeavor Health, Evanston, IL, USA.
Mara PiltinDepartment of Surgery, Mayo Clinic, Jacksonville, FL, USA.
James JakubDepartment of Surgery, Mayo Clinic, Jacksonville, FL, USA.
Sara JavidDepartment of Surgery, University of Washington, Seattle, WA, USA.
Meghan R FlanaganDepartment of Surgery, University of Washington, Seattle, WA, USA.
Rebecca AftDepartment of Surgery, Washington University, St. Louis, MO, USA.
Akiko ChibaDepartment of Surgery, Duke University, Durham, NC, USA.
Alysandra LalDepartment of Surgery, Ascension Columbia St. Mary's Hospital, Milwaukee, WI, USA.
Ari D BrooksDepartment of Surgery, University of Pennsylvania, Philadelphia, PA, USA.
Farin AmersiDepartment of Surgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
Nayana DekhneDepartment of Surgery, Corewell Health, Royal Oak, MI, USA.
Jennifer TsengDepartment of Surgery, City of Hope Comprehensive Cancer Center, Irvine, CA, USA.
Clara FarleyDepartment of Surgery, Emory University, Atlanta, GA, USA.
Alan KadisonDepartment of Surgery, Northwell Health, Lake Success, NA, USA.
Jeffrey JohnsonDepartment of Surgery, Mayo Clinic, Rochester, MN, USA.
Rosa F HwangDepartment of Breast Surgical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA. rhwang@mdanderson.org.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis prospective randomized trial evaluated the safety and effectiveness of robotic-assisted nipple-sparing mastectomy (rNSM) using the da Vinci Single Port (SP) PATIENTS AND

methodsThis Food and Drug Administration (FDA) investigational device exemption (IDE)-approved, two-arm, multicenter randomized controlled trial (RCT) randomized eligible women (clinical Tis-T2, N0) 1:1 to rNSM or open NSM with immediate implant-based reconstruction. Operations were performed at 14 US sites by 23 surgeons. Primary endpoints included conversion to open surgery, adverse events at 42 days, and positive surgical margin (PSM) rates. Secondary outcomes included operative time, estimated blood loss, nipple-areolar complex (NAC) and skin flap viability, final pathology, and patient-reported outcomes (BREAST-Q).

resultsOverall, 74 patients completed surgery, totaling 65 rNSM (38 therapeutic, 27 prophylactic) and 66 open NSM (38 therapeutic, 28 prophylactic). Operative time was longer for rNSM (141.6 versus 83.9 min) with no conversions to open surgery. Serious adverse events (SAEs) occurred in three rNSM and eight open NSM patients, with no device-related SAEs reported. NAC preservation at 42 days was 100% for rNSM and 98.5% for open NSM. PSM rates were identical (six patients each). Higher BREAST-Q scores favored rNSM in multiple domains.

conclusionsThese results demonstrate that da Vinci SP

Indexed as

Breast NeoplasmsMastectomyNipplesOrgan Sparing TreatmentsRobotic Surgical ProceduresAdultAgedFemaleFollow-Up StudiesHumansMiddle AgedOperative TimePostoperative ComplicationsPrognosisProspective Studies

Identifiers

PMID42463607
PMCPMC13630962

What OpenQuestion holds

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.