Is it possible to run a clinical research study to investigate the role of mesh in implant-based breast reconstruction surgery?
| ISRCTN | ISRCTN17470747 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17470747 |
| IRAS number | 301423 |
| ClinicalTrials.gov number | NCT06112977 |
| Secondary identifying numbers | IRAS 301423, CPMS 58112 |
- Submission date
- 19/06/2023
- Registration date
- 20/10/2023
- Last edited
- 11/03/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Breast cancer affects one in eight women. 55,000 women are diagnosed in the UK per year. Over 40% of women needing surgery require mastectomy and may be offered breast reconstruction with an implant if suitable. Since 2015, surgeons have been using a mesh to provide additional cover and support to the implant placed on the chest wall muscles for cosmesis. Mesh costs up to £2500 per breast and uncertainty exists about its benefits and risks to patients. Meshes have been reported in academic literature to potentially increase certain post-operative problems (complications) whereas the mesh industry reports benefits.
We do not have good-quality evidence to guide patients on the risks and benefits of using mesh in breast reconstruction. Therefore, we cannot determine whether using mesh or not is better. Surgeons do have alternative techniques to using mesh which have been shown to be safe. If breast reconstruction is acceptable without mesh, patients may avoid complications associated with mesh use. The NHS could divert resources from mesh towards other patient needs.
The best way to evaluate mesh is a randomised controlled trial (RCT) where we compare the health of the women who receive different treatments to decide which is cost-effective. This type of study can be challenging and costly; currently we do not know if women and surgeons are willing to take part.
The aim of this study is to carry out a feasibility trial to evaluate breast reconstruction surgery without and with mesh in patients requiring mastectomy to proceed to a definitive RCT.
Who can participate?
Women aged 19 years and over who have decided with their surgeon to proceed to an immediate prepectoral (above the muscle) implant-based breast reconstruction after mastectomy (for cancer treatment or risk reduction).
What does the study involve?
Participants will be asked to fill in a questionnaire before their surgery and on the day of surgery will be randomly allocated to either receive an implant-based breast reconstruction with mesh or without mesh in the above muscle position (prepectoral). After surgery participants will be told which operation they had on day 90 of their recovery, after completing a post-operative questionnaire. There are two sub-studies which participants will also be offered to participate in: having an interview with a researcher about their views on mesh and the study design, and having breast movement before and after surgery (biomechanics) measured at the University of Portsmouth.
Where is the study run from?
University of Oxford (UK)
When is the study starting and how long is it expected to run for?
March 2021 to August 2025
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)
Who is the main contact?
Ms Rachel Rolph, rachel.rolph@nds.ox.ac.uk
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-mesh-assisted-breast-implant-reconstruction-surgery-restore-b
Contact information
Principal Investigator
St Johns' College
University of Oxford
Oxford
OX1 3JP
United Kingdom
 ORCID ID |
0000-0002-1425-4322 |
|---|---|
| Phone | +44 (0)1865 227374 |
| rachel.rolph@sjc.ox.ac.uk |
Scientific
Surgical Trials Intervention Unit (SITU)
Nuffield Department of Surgical Sciences
John Radcliffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom
| Phone | +44 (0)1865 612268 |
|---|---|
| restoreb@nds.ox.ac.uk |
Study information
| Study design | Multicentre prospective single-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | A mixed-methods multi-centre randomised controlled trial comparing no-mesh to mesh-assisted breast reconstruction surgery: the Restore-B (NoMesh) Study |
| Study acronym | Restore-B |
| Study objectives | Is it feasible to run a large multi-centre randomised single blinded controlled trial comparing immediate prepectoral breast reconstruction (expander or implant based) with and without the use of mesh (synthetic or biological). |
| Ethics approval(s) |
Approved 03/10/2023, South Central – Hampshire B Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, United Kingdom; +44 (0)207 104 8088, +44 (0)207 104 8289, +44 (0)207 104 8189; hampshireb.rec@hra.nhs.uk), ref: 23/SC/0302 |
| Health condition(s) or problem(s) studied | Mastectomy for treatment or prevention of breast cancer |
| Intervention | Randomisation will be a 1:1 allocation between the two intervention arms via the online database REDcap. Participants are randomised to immediate breast reconstruction using an implant or expander in the prepectoral plane with or without the use of surgical mesh (synthetic mesh or biological acellular dermal matrix). Patients will be blinded to their allocation. Feasibility outcome data alongside patient-reported quality of life and clinical complication data will be collected. A provisional economic analysis of the two arms alongside a blinded cosmetic assessment will be performed. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Feasibility outcomes measured using quantitative trial database: 1. Number of women eligible for the study in 12 months 2. Number of women recruited in 12 months 3. Number of women randomized in 12 months 4. Number of women blinded to 90 days in 12 months |
| Secondary outcome measures | 1. Clinical outcome measures, measured using patient medical records at 90 days: number of women with the following: infection (requiring treatment), seroma (requiring drainage), reoperation, haematoma, mesh removal, implant removal 2. Patient-reported quality of life measured by EQ5D and Breast Q questionnaires pre- and post-operatively at 90 days 3. Aesthetic scoring: blinded independent assessment of interventions by a panel of health professionals at 90 days postoperatively 4. Exploratory economic analysis of two arms using weekly patient reported diaries from day 7-90 postoperatively |
| Overall study start date | 01/03/2021 |
| Completion date | 31/08/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 19 Years |
| Sex | Female |
| Target number of participants | 40 |
| Key inclusion criteria | 1. Women aged >18 years 2. Participant is willing and able to give informed consent for participation in the trial 3. Eligible for prepectoral implant-based breast reconstruction with implant or expander with mesh (synthetic or biologic) for cancer treatment or risk reduction surgery |
| Key exclusion criteria | 1. Participant is pregnant, lactating or planning pregnancy during the trial 2. Patient refusal 3. Delayed breast reconstruction following simple mastectomy |
| Date of first enrolment | 01/11/2023 |
| Date of final enrolment | 31/08/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
London
SW3 6JJ
United Kingdom
Downs Road
Sutton
SM2 5PT
United Kingdom
Tremona Road
Southampton
SO16 6YD
United Kingdom
Southwick Hill Road
Cosham
Portsmouth
PO6 3LY
United Kingdom
London
NW1 2PQ
United Kingdom
Reading
RG1 5AN
United Kingdom
Sponsor information
University/education
RGEA
Oxford
OX3 7GB
England
United Kingdom
| Phone | +44 (0)1865 289884 |
|---|---|
| rgea.sponsor@admin.ox.ac.uk | |
| Website | http://www.ox.ac.uk/ |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 10/01/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated analysed during the current study will be published as a supplement to a results publication. |
Editorial Notes
11/03/2025: The recruitment end date was changed from 01/03/2025 to 31/08/2025.
10/03/2025: The overall study end date was changed from 01/08/2025 to 31/08/2025.
04/11/2024: Cancer Research UK link added to plain English summary field.
19/02/2024: The following changes were made to the trial record:
1. The ClinicalTrials.gov number was added.
2. The recruitment end date was changed from 01/11/2024 to 01/03/2025.
3. The study website was added.
4. The overall end date was changed from 01/02/2025 to 01/08/2025.
12/10/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
