RESTORE B

RESTORE B

A mixed-methods study evaluating the feasibility of a future multi-centre randomised controlled trial comparing no-mesh to mesh-assisted pre-pectoral breast reconstruction surgery. (ClinicalTrials.gov: NCT06112977; ISRCTN: ISRCTN17470747)

Overview

Immediate implant-based prepectoral breast reconstruction is gaining popularity both nationally and internationally. Currently, many surgeons use mesh within this operation to wrap the implant and shape the reconstructive pocket. Following patient advocacy on mesh complications in gynaecological surgery, there is a growing interest by the public and policy makers to evaluate the evidence and role of mesh across other specialties. 

This is a feasibility study to understand if it is possible to recruit into a trial randomising patients to receive mesh or not in their immediate prepectoral implant-based breast reconstruction operation. This study will collect valuable information on the safety profile of the no-mesh prepectoral breast reconstruction and which outcome measures matter most to surgeons and patients for this operation. Data will inform a future RCT, should the trial be feasible to run. 

Objectives

The specific things we want to learn are:

• What reconstructive surgeons think about randomising to no-mesh surgery and their willingness to participate in the study.
• What patients understand about mesh and their views on participating in the study.
• What are the estimated costs of the two reconstructive techniques?
• Is it possible to collect pre- and post-biomechanical data on the two reconstructive techniques?

Methods

Eligible patients will be invited to join the study if they are due to have this operation. Participants will be randomly allocated at surgery to receive mesh or not. Study participants will not know their allocation until day 90 post operatively. They will be followed up with routine NHS standard of care. We will collect additional information on their quality of life in the two groups and access to healthcare services post operatively. 
We will interview participants and surgeons for their views on this trial. 

Inclusion/ exclusion criteria

Inclusion: 
Women with a diagnosis of breast cancer or a gene mutation predisposing to breast cancer undergoing immediate pre- pectoral implant-based breast reconstruction will be eligible to participate in the trial. Women must be over 18 years of age, willing and able to give informed consent and able to comply with all trial requirements. 

Exclusion:                     
Patients are unable to enter the trial if the participant becomes pregnant or is planning pregnancy or breast feeding; refuses to enter the trial or is undergoing delayed breast reconstruction post simple mastectomy. 

Planned sample size: 40 patients    
Total number of sites: 5
Timeline: February 2024- August 2025