Breast CancerNCT06112977
Restore-B: A Trial Comparing Prepectoral Implant-based Breast Reconstruction With and Without Mesh
A study testing Prepectoral implant-based immediate breast reconstruction in people with Breast Cancer and Risk Reduction, run by University of Oxford at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Risk Reduction
- What is being tested?
- Prepectoral implant-based immediate breast reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2023to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women > 18 years
- Participant is able and willing to give informed consent for participation in the trial
- Eligible for immediate prepectoral implant-based breast reconstruction with implant or expander with mesh (biologic or synthetic) for cancer treatment or risk reduction surgery.
- In the Investigator's opinion, can comply with all trial requirements.
Who cannot join
- The participant may not enter the trial if any of the following apply:
- Participant is pregnant, lactating or planning pregnancy during the trial
- Patient refusal
- Delayed breast reconstruction post simple mastectomy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Surigcal Intervention Trials Unit (SITU), Nuffield Department of Surgical Sciences, University of Oxford
Oxford, Oxfordshire, OX3 9DU
About this study
Official title: 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
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:
Read more
- To determine the feasibility of a definitive RCT comparing the clinical and cost- effectiveness of no- mesh versus mesh- assisted pre-pectoral breast reconstruction.
- To determine if it is possible to collect data to inform a future economic analysis on the use of mesh in breast reconstruction.
Participants will be randomly allocated to have their breast reconstruction either with the use of mesh or without the use of mesh prior to the start of the operation. Participants will be blinded to their allocation until day 90 post operatively. Participants will be asked to have medical photography and to complete a short quality of life questionnaire before and after surgery at 90 days prior to finding out their allocation.
Read the detailed description
Trial Design:
Restore-B is a prospective, multicentre parallel 2-armed single-blinded randomised controlled feasibility trial comparing no-mesh to mesh- assisted immediate implant-based prepectoral breast reconstruction surgery.
Patients will be randomised 1:1 to either the intervention surgery (no- mesh) arm or the control arm surgery (mesh-assisted).
Planned Trial Period:
The overall period of the trial is:
12 months recruitment, 3 months follow-up and 6 months data analysis and final reporting of results.
Trial Participants:
Women over 18 years old eligible for elective immediate prepectoral implant-based breast reconstruction with mesh for cancer treatment or risk reduction surgery
Intervention:
Immediate prepectoral implant-based (implant or expander) breast reconstruction without surgical mesh (ADM or synthetic).
Comparator:
Immediate prepectoral implant- based (implant or expander) breast reconstruction with surgical mesh (ADM or synthetic) (standard of care).
- Conditions
- Breast Cancer, Risk Reduction
- Being tested
- Prepectoral implant-based immediate breast reconstruction
- Keywords
- Breast surgery, Breast Reconstruction, Prepectoral, Implant, Mesh, Acellular dermal matrix
- Medical subject headings
- Breast Neoplasms, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prepectoral implant-based immediate breast reconstructionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate prepectoral implant-based breast reconstruction without surgical mesh. | Active comparator | Prepectoral implant (expander or fixed volume) breast reconstruction without mesh Receives: Procedure: Prepectoral implant-based immediate breast reconstruction |
| Immediate prepectoral implant- based breast reconstruction with surgical mesh | Active comparator | Prepectoral implant (expander or fixed volume) breast reconstruction with mesh (biological or synthetic) Receives: Procedure: Prepectoral implant-based immediate breast reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (%)
Measured: 16 months
Secondary outcomes (3)
Clinical outcomes in each arm
- Number of clinical complications in each arm up to 90 days: seroma, infection, re-operation, haematoma, mesh removal, implant removal, revision surgery
Measured: 90 days
Patient reported outcome: Breast-Q Breast Reconstruction Quality of Life (QoL) Measure
Breast Q measures health related QoL and patient satisfaction in the context of breast surgery. The breast reconstruction module will be used in this study and measured pre- and post-operatively in each arm.
All BREAST-Q scales are transformed into scores that range from 0-100, independent of the type and number of modules. The scores are computed by adding the response items together and then converting the raw sum scale score to a score from 0-100. For all BREAST-Q scales, a higher score means greater satisfaction or better QOL (depending on the scale).
Measured: 90 days post operatively
Patient reported outcome: EuroQoL-EQ5D Quality of Life (QoL) Measure
Quality of life (QoL) questionnaires pre-and post-operatively at 90 days measured by EuroQol-EQ5D-5L.
This QoL questionnaire comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems (1-5). The patient is asked to indicate her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. A higher score indicates more severe or frequent problems.
Measured: 90days post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Restore-B is a prospective, multicentre parallel 2-armed single-blinded randomised controlled feasibility trial comparing no-mesh to mesh- assisted immediate implant-based prepectoral breast reconstruction surgery. Patients will be randomised 1:1 to either the intervention surgery (no- mesh) arm or the control arm surgery (mesh-assisted).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Ms Rachel Rolph, MBBS MA FRCS, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112977
- Sponsor's protocol ID
- Restore-B
- Status last verified
- Oct 2023
- First submitted
- 10 Oct 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 41106857
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06112977
- Acronym / sponsor ID
- Restore-B
- Conditions
- Breast Cancer, Risk Reduction
- Keywords
- Breast surgery, Breast Reconstruction, Prepectoral, Implant, Mesh, Acellular dermal matrix
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine the feasibility of a definitive RCT comparing the clinical and cost- effectiveness of no- mesh versus mesh- assisted pre-pectoral breast reconstruction.
- To determine if it is possible to collect data to inform a future economic analysis on the use of mesh in breast reconstruction.
Participants will be randomly allocated to have their breast reconstruction either with the use of mesh or without the use of mesh prior to the start of the operation. Participants will be blinded to their allocation until day 90 post operatively. Participants will be asked to have medical photography and to complete a short quality of life questionnaire before and after surgery at 90 days prior to finding out their allocation.
Detailed description
Trial Design:
Restore-B is a prospective, multicentre parallel 2-armed single-blinded randomised controlled feasibility trial comparing no-mesh to mesh- assisted immediate implant-based prepectoral breast reconstruction surgery.
Patients will be randomised 1:1 to either the intervention surgery (no- mesh) arm or the control arm surgery (mesh-assisted).
Planned Trial Period:
The overall period of the trial is:
12 months recruitment, 3 months follow-up and 6 months data analysis and final reporting of results.
Trial Participants:
Women over 18 years old eligible for elective immediate prepectoral implant-based breast reconstruction with mesh for cancer treatment or risk reduction surgery
Intervention:
Immediate prepectoral implant-based (implant or expander) breast reconstruction without surgical mesh (ADM or synthetic).
Comparator:
Immediate prepectoral implant- based (implant or expander) breast reconstruction with surgical mesh (ADM or synthetic) (standard of care).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Restore-B is a prospective, multicentre parallel 2-armed single-blinded randomised controlled feasibility trial comparing no-mesh to mesh- assisted immediate implant-based prepectoral breast reconstruction surgery. Patients will be randomised 1:1 to either the intervention surgery (no- mesh) arm or the control arm surgery (mesh-assisted).
| Arm | Type | Receives |
|---|---|---|
| Immediate prepectoral implant-based breast reconstruction without surgical mesh. | Active comparator | Procedure: Prepectoral implant-based immediate breast reconstructionPrepectoral implant (expander or fixed volume) breast reconstruction without mesh |
| Immediate prepectoral implant- based breast reconstruction with surgical mesh | Active comparator | Procedure: Prepectoral implant-based immediate breast reconstructionPrepectoral implant (expander or fixed volume) breast reconstruction with mesh (biological or synthetic) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women > 18 years
- Participant is able and willing to give informed consent for participation in the trial
- Eligible for immediate prepectoral implant-based breast reconstruction with implant or expander with mesh (biologic or synthetic) for cancer treatment or risk reduction surgery.
- In the Investigator's opinion, can comply with all trial requirements.
Key exclusion criteria (4 listed)
- Participant is pregnant, lactating or planning pregnancy during the trial
- Patient refusal
- Delayed breast reconstruction post simple mastectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prepectoral implant-based immediate breast reconstructionPrepectoral 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. | Procedure or surgery | Immediate prepectoral implant- based breast reconstruction with surgical mesh, Immediate prepectoral implant-based breast reconstruction without surgical mesh. |
Primary outcome
Feasibility of a definitive RCT comparing the clinical and cost- effectiveness of no- mesh versus mesh- assisted pre-pectoral breast reconstruction.
Time frame: 16 months
* 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 (%)
3 secondary outcomes
Clinical outcomes in each arm
Time frame: 90 days
Patient reported outcome: Breast-Q Breast Reconstruction Quality of Life (QoL) Measure
Time frame: 90 days post operatively
Patient reported outcome: EuroQoL-EQ5D Quality of Life (QoL) Measure
Time frame: 90days post operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Derived from this study: PubMed 41106857Rolph 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ms Rachel Rolph, MBBS MA FRCS principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prepectoral implant-based immediate breast reconstruction in people with Breast Cancer and Risk Reduction, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of a definitive RCT comparing the clinical and cost- effectiveness of no- mesh versus mesh- assisted pre-pectoral breast reconstruction. (time frame: 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06112977, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.