Evidence map›Paper›PMID 41106857›Full record

ArticleBMJ open2025

Prepectoral no mesh versus mesh immediate implant-based reconstruction after mastectomy (Restore-B): a multicentre single-blinded randomised controlled feasibility study protocol.

Rachel Rolph, Sue Ziebland, Jonathan Alistair Cook, Cynthia Iglesias, Joanna Wakefield-Scurr, Charles Malyon, Jessica Scaife, Amy Taylor, Aimee Hennessy, Sarah Markham and 3 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06112977 (Restore-B), which is not on this 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.

NCT06112977 naunknown statusnot on this map

Restore-B: A Mixed-methods Trial Evaluating the Feasibility of a Multi-centre Randomised Controlled Trial Comparing No-mesh to Mesh-assisted Immediate Prepectoral Implant-based Breast Reconstruction

TypeinterventionalSponsorUniversity of OxfordRan2023 to 2025Enrolled40ConditionsBreast Cancer, Risk ReductionArmsPrepectoral implant-based immediate breast reconstruction
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

13 authors.

Rachel RolphNuffield Department of Surgical Sciences, University of Oxford, Oxford, UK rachel.rolph@sjc.ox.ac.uk.ORCID http://orcid.org/0009-0003-8713-9573
Sue ZieblandMedical Sociology and Health Experiences Research Group, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Jonathan Alistair CookCentre for Statistics in Medicine, Nuffield Department of Orthopaedic, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.ORCID http://orcid.org/0000-0002-4156-6989
Cynthia IglesiasHealth Services and Policy Research, Department of Health Sciences, University of York, York, UK.ORCID http://orcid.org/0000-0002-3426-0930
Joanna Wakefield-ScurrSchool of Sport, Health and Exercise Science, Spinnaker Building, University of Portsmouth, Portsmouth, UK.
Charles MalyonNuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.
Jessica ScaifeNuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.
Amy TaylorNuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.
Aimee HennessyNuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.
Sarah MarkhamNuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.
Marcelle BernsteinNuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.
Michael DouekNuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.
Restore-B Feasibility Collaborative Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionBreast cancer is common and women requiring mastectomy will be offered a breast reconstruction if they are surgically suitable candidate. Breast reconstruction can be performed at the same time as the mastectomy (immediate) or delayed to a second operation after cancer treatments. The reconstruction can either use the patients' own tissue to make the breast (autologous) or use a prosthesis to make the breast in the form of a fixed or expandable volume implant (implant-based breast reconstruction, IBBR). Immediate breast reconstruction on top of the chest wall muscles (prepectoral) is performed worldwide. This operation involves the use of a synthetic or biological mesh placed around the implant under the skin. Increasingly, surgeons are performing this technique without the use of mesh. Both techniques, with and without mesh, have not been compared in a head-to-head randomised controlled trial (RCT); therefore, surgeons and patients do not have high quality data to guide their decision making in this area. METHODS AND ANALYSIS: UK-based pragmatic multicentre randomised controlled feasibility trial. The primary aim is to determine the feasibility of a definitive RCT comparing the clinical and cost-effectiveness of no-mesh versus mesh-assisted prepectoral breast reconstruction. Secondary objectives will explore patient understanding of mesh and willingness to be randomised within an RCT; determine if it is possible to collect data to inform a future economic analysis on the use of mesh in breast reconstruction and determine the feasibility of measuring breast biomechanics pre-surgery and post breast reconstruction surgery. Total number of patients to be included: 40 (20 per arm). ETHICS AND DISSEMINATION: This study will be conducted in compliance with the Declaration of Helsinki. Ethical approval has been obtained. Ethics Ref: 23/SC/0302; IRAS Project ID: 301 423. The results of this study will be published in a peer-reviewed medical journal, independent of the results, following the Consolidated Standards of Reporting Trials standards for RCTs. TRIAL REGISTRATION NUMBERS: NCT06112977; ISRCTN17470747.

Indexed as

Breast ImplantationBreast ImplantsBreast NeoplasmsMammaplastyMastectomySurgical MeshCost-Benefit AnalysisFeasibility StudiesFemaleHumansMulticenter Studies as TopicPectoralis MusclesPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicSingle-Blind MethodBreast surgeryPatientsRandomized Controlled Trial

Identifiers

PMID41106857
PMCPMC12542532

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Registered trials

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.