Restore-B: A Trial Comparing Prepectoral Implant-based Breast Reconstruction With and Without Mesh

NCT06112977 | Unknown

• 1 other identifier: Restore-B
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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

Breast Cancer; Risk Reduction

Keywords

Breast surgery; Breast Reconstruction; Prepectoral; Implant; Mesh; Acellular dermal matrix

Outcome Measures

Primary Outcomes (1)

• 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 (%)

  16 months

Secondary Outcomes (3)

• Clinical outcomes in each arm

  90 days

• Patient reported outcome: Breast-Q Breast Reconstruction Quality of Life (QoL) Measure

  90 days post operatively

• Patient reported outcome: EuroQoL-EQ5D Quality of Life (QoL) Measure

  90days post operatively

Study Arms (2)

Immediate prepectoral implant-based breast reconstruction without surgical mesh.

ACTIVE COMPARATOR

Prepectoral implant (expander or fixed volume) breast reconstruction without mesh

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)

Procedure: Prepectoral implant-based immediate breast reconstruction

Interventions

Prepectoral implant-based immediate breast reconstruction PROCEDURE

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.

Immediate prepectoral implant- based breast reconstruction with surgical mesh; Immediate prepectoral implant-based breast reconstruction without surgical mesh.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Surigcal Intervention Trials Unit (SITU), Nuffield Department of Surgical Sciences, University of Oxford

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 41106857 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Ms Rachel Rolph, MBBS MA FRCS

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to their surgical allocation (mesh or no mesh) and will be unblinded after completion of their post-operative questionnaire at day 90.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: November 2, 2023
• Study Start: November 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: February 1, 2025
• Last Updated: November 2, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 3 months. Available long term
• Access Criteria: Open access publication of the protocol in British Medical Journal Open Scientific Journal.

Locations

GB (1)