A study looking at mesh assisted breast implant reconstruction surgery (RESTORE-B)
Cancer type:
Status:
Phase:
This study is comparing mesh assisted breast implant surgery with non mesh assisted breast implant surgery.
It is open to women who are having an 
using an implant after a mastectomy:
- as part of their cancer treatment or
- to reduce the risk of cancer developing in the future because you have a gene change (mutation)
This is a to find out if the researchers could do a larger trial in the future.
More about this trial
A mastectomy is surgery to remove all of the breast. You might have a mastectomy as part of your cancer treatment or to reduce the risk of developing cancer if you have a known gene change.
When you have a mastectomy you might have breast reconstruction surgery at the same time. This is called immediate implant reconstruction. Or you might have it some months or years afterwards. This is called delayed reconstruction.
As part of the reconstruction the surgeon can use a mesh sometimes referred to as an acellular dermal matrix (ADM). They put the mesh around the implant which sits on top of the chest wall muscles (pectoral). This may help to keep the implant or in place and to create a natural breast shape droop. Not all surgeons use a mesh. And it is not known which is best, using the mesh or not using the mesh as some research suggests that using the mesh may increase post operative complications
To find out which is best researchers need to do a large, comparing reconstruction surgery using the mesh with not using the mesh.
Before doing a large, randomised trial they need to find out if it is possible to run such a trial. And whether women would accept being put into a group at random and not know which group they were put into until the study ended (blinded). This is called a feasibility study.
The aim of this feasibility study is to find out:
- whether it is possible to do a large randomised clinical trial
- what women understand about the mesh
- their willingness to take part in a clinical trial comparing reconstruction surgery using a mesh with reconstruction surgery not using a mesh
- whether it is possible to collect information about the results and acceptability of the reconstruction
Who can enter
The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join if all the following apply. You are a woman:
- having immediate breast reconstruction surgery following a mastectomy either as part of your cancer treatment or to reduce the risk of cancer developing because you have a gene change (
mutation ) - having an implant or an expander with a mesh placed above the muscle (pectoral)
- at least 19 years old
Who can’t take part
You cannot join this study if any of these apply. You are:
● having delayed reconstruction surgery after a mastectomy
● pregnant, breastfeeding or planning to become pregnant
Trial design
This is a feasibility study. The team need 40 women to take part.
When you see the surgeon to talk about the surgery, they will also discuss the RESTORE-B study. The team will ask to tape record the session. You don’t have to agree to have the session taped. You can still take part in the study.
Whether you agree to take part in the study or not the team would like to interview you. This is done online at a time convenient to you. The team want to find out what you think about the RESTORE-B study. You don’t have to agree to this interview even if you agreed to take part in the study.
This is a randomised study. A computer puts you into a group. Neither you nor your surgeon can choose which group you are in. Neither will you know which group you are in before your surgery. Your surgeon will know just before you have your surgery. The groups are reconstruction surgery:
- using mesh
- not using mesh
You have your surgery as planned. The team tell you whether you have the mesh or not 3 months after surgery after completing your post operative questionnaire.
The study team will also take photos of your breast:
- before surgery
- 3 months after surgery
You will not be able to be identified in the photo and this is routinely performed as part of the breast reconstruction surgery.
Quality of life
You fill in a questionnaire before you have surgery and 3 months after surgery. The questions ask about:
- your general health and wellbeing
- any complications
- what you can do in your daily life
This is a quality of life questionnaire.
Diary
After surgery you keep a diary. You will fill this in every week for 3 months after surgery. This is to let the research team know if you have experienced any additional problems following surgery and what you have done to be assessed and treated. For example contacting your family doctor because you need extra wound dressings.
You can do this online through your computer or phone. The team can give you a paper diary to fill in if you prefer.
Breast movement – optional sub study
The team want to find out how your breast movement and shape changes after surgery. To do this they take a special scan of your breast before surgery and 3 months after surgery.
The scan takes 60 minutes. You go to Portsmouth University for the scans. The team will pay your travel costs.
The team will have a tailor-made bra for you to wear after surgery if you decide take part in this sub study. You don’t have to take part in this sub study and still take part in the main study.
Hospital visits
You see the doctor before you agree to take part in this study. This is to discuss the RESTORE-B study.
After surgery you see the doctor at:
- 2 weeks
- 1 month
- 3 months
Side effects
We have more information about breast reconstruction surgery using an implant.
Location
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Rachel Rolph
Supported by
National Institute for Health Research (NIHR)
University of Oxford
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
