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
Sponsor study identifier
interventional
40
1 country
1
Study Start
November 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The goal of this feasibility randomised controlled clinical trial (RCT) is to compare mesh-assisted to no-mesh pre-pectoral implant based immediate breast reconstruction in women undergoing mastectomy for treatment of breast cancer or for risk reduction of an inherited breast cancer risk. The main questions it aims to answer are:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 10, 2023
Actual (reported)November 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 2, 2023
Actual (reported)November 1, 2024
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February 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Feasibility of a definitive RCT comparing the clinical and cost- effectiveness of no- mesh versus mesh- assisted pre-pectoral breast reconstruction.
* Number of patients eligible * Number of patients consented and randomised within 12 months recruitment * Number of patients lost to follow up/withdrawal * Completeness of data per participant (%)
16 months
Clinical outcomes in each arm
90 days
Patient reported outcome: Breast-Q Breast Reconstruction Quality of Life (QoL) Measure
90 days post operatively
Patient reported outcome: EuroQoL-EQ5D Quality of Life (QoL) Measure
90days post operatively
Prepectoral implant (expander or fixed volume) breast reconstruction without mesh
Prepectoral implant (expander or fixed volume) breast reconstruction with mesh (biological or synthetic)
Prepectoral implant based breast reconstruction is an immediate breast reconstruction whereby a fixed volume implant or expander is placed on top of the chest wall muscle (Pectoralis Major) to reconstruct the breast after mastectomy.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Surigcal Intervention Trials Unit (SITU), Nuffield Department of Surgical Sciences, University of Oxford
Oxford, Oxfordshire, OX3 9DU, United Kingdom
Rolph R, Ziebland S, Cook JA, Iglesias C, Wakefield-Scurr J, Malyon C, Scaife J, Taylor A, Hennessy A, Markham S, Bernstein M, Douek M; Restore-B Feasibility Collaborative Group. Prepectoral no mesh versus mesh immediate implant-based reconstruction after mastectomy (Restore-B): a multicentre single-blinded randomised controlled feasibility study protocol. BMJ Open. 2025 Oct 17;15(10):e103278. doi: 10.1136/bmjopen-2025-103278.
Ms Rachel Rolph, MBBS MA FRCS
University of Oxford
First Submitted
October 10, 2023
First Posted
November 2, 2023
Study Start
November 1, 2023
Fluciclovine (18F) Imaging of Breast Cancer
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 2, 2023
Record last verified: 2023-10
The study protocol will be published for reference. Study outcome data will be published at the end of the trial. Data will determine progression to full RCT.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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