The pre-pectoral breast reconstruction evaluation study

Not Applicable

Completed

• Conditions: Breast reconstruction; Surgery

• Registration Number: ISRCTN11898000
• Lead Sponsor: niversity of Bristol

Brief Summary

2020 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31988232 protocol (added 09/04/2020) 2022 Results article in https://doi.org/10.1093/bjs/znac077 (added 18/07/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-08
• Study Completion: 2022-09-30
• Last Update Posted: 2 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 347

Inclusion Criteria

Consecutive women >16 who require a mastectomy for breast cancer or risk-reduction who:
1. Elect to undergo immediate implant-based breast reconstruction
2. Considered suitable for PPBR by their surgeon
3. Understand and accept that PBRR is innovative and that outcome data are limited

Exclusion Criteria

Absolute exclusion criteria:
1. Thin/ insufficiently vascularised skin-flaps as assessed by the operating surgeon
2. Revision /delayed breast reconstruction

Additional relative exclusion criteria applied in line with the ABS/BAPRAS guidelines for mesh-assisted breast reconstruction for surgeons in the learning phase or early practice of prepectoral breast reconstruction:
1. Smokers or ex-smokers <6 weeks
2. Previous radiotherapy to the ipsilateral breast/chest wall
3. BMI >30 (except for dermal sling procedures)
4. Implant size >600cc
5. Anticipated post-mastectomy radiotherapy
6. Poorly controlled diabetes

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measure as of 08/04/2020:<br> Implant loss rate at 3 months defined as: any unplanned removal of the implant without replacement of the prosthesis (implant or expander) for infection, wound problems or other indication within the first 3 months following surgery<br><br> Previous primary outcome measure:<br> Implant loss rate at 3 months will be determined by clinical review carried out by participating surgeons at participating clinical sites. Implant loss is defined as: any unplanned removal of the implant without replacement of the prosthesis (implant or expander) for infection, wound problems or other indication within the first 3 months following surgery.<br>