Clinical trial · Interventional
Restore-B: A Trial Comparing Prepectoral Implant-based Breast Reconstruction With and Without Mesh
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Risk Reduction | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prepectoral implant-based immediate breast reconstruction | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Immediate prepectoral implant-based breast reconstruction without surgical mesh.
- description
- Prepectoral implant (expander or fixed volume) breast reconstruction without mesh
- interventionNames
- Procedure: Prepectoral implant-based immediate breast reconstruction
- type
- ACTIVE_COMPARATOR
- label
- Immediate prepectoral implant- based breast reconstruction with surgical mesh
- description
- Prepectoral implant (expander or fixed volume) breast reconstruction with mesh (biological or synthetic)
- interventionNames
- Procedure: Prepectoral implant-based immediate breast reconstruction
Primary outcomes (1)
- measure
- Feasibility of a definitive RCT comparing the clinical and cost- effectiveness of no- mesh versus mesh- assisted pre-pectoral breast reconstruction.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: 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
References
Publications (1)
- DERIVEDRolph 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. PMID 41106857