Clinical trial NCT06112977: Restore-B: A Trial Comparing Prepectoral Implant-based Breast Reconstruction With and Without Mesh
Official title: 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Breast Cancer
Risk Reduction
Keywords: Breast surgery
Breast Reconstruction
Prepectoral
Implant
Mesh
Acellular dermal matrix
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2023-11-02
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of a definitive RCT comparing the clinical and cost- effectiveness of no- mesh versus mesh- assisted pre-pectoral breast reconstruction.
timeFrame: 16 months
Secondary outcomes:
measure: Clinical outcomes in each arm
timeFrame: 90 days
measure: Patient reported outcome: Breast-Q Breast Reconstruction Quality of Life (QoL) Measure
timeFrame: 90 days post operatively
measure: Patient reported outcome: EuroQoL-EQ5D Quality of Life (QoL) Measure
timeFrame: 90days post operatively
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Surigcal Intervention Trials Unit (SITU), Nuffield Department of Surgical Sciences, University of Oxford
state: Oxfordshire
Study officials:
affiliation: University of Oxford
name: Ms Rachel Rolph, MBBS MA FRCS
role: PRINCIPAL_INVESTIGATOR
References: