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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2025-02-01

Brief Summary

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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.

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RECRUITING

Detailed Description

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Trial Design:

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).

Planned Trial Period:

The overall period of the trial is:

12 months recruitment, 3 months follow-up and 6 months data analysis and final reporting of results.

Trial Participants:

Women over 18 years old eligible for elective immediate prepectoral implant-based breast reconstruction with mesh for cancer treatment or risk reduction surgery

Intervention:

Immediate prepectoral implant-based (implant or expander) breast reconstruction without surgical mesh (ADM or synthetic).

Comparator:

Immediate prepectoral implant- based (implant or expander) breast reconstruction with surgical mesh (ADM or synthetic) (standard of care).

Conditions

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Breast Cancer Risk Reduction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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.

Study Groups

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Immediate prepectoral implant-based breast reconstruction without surgical mesh.

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

Group Type ACTIVE_COMPARATOR

Prepectoral implant-based immediate breast reconstruction

Intervention Type 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

Prepectoral implant (expander or fixed volume) breast reconstruction with mesh (biological or synthetic)

Group Type ACTIVE_COMPARATOR

Prepectoral implant-based immediate breast reconstruction

Intervention Type 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.

Interventions

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Prepectoral implant-based immediate breast reconstruction

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No