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

NCT06112977 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-11-02

No results posted yet for this study

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

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • University of Oxford

    lead OTHER

Principal Investigators

  • Ms Rachel Rolph, MBBS MA FRCS · University of Oxford

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2024-11-01
Completion
2025-02-01

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06112977 on ClinicalTrials.gov