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Comparison of Patient Reported Outcome Measures Using the BREAST-Q Questionnaire in Patients Undergoing Pre Versus Sub-pectoral Implant Based Immediate Breast Reconstruction.

NCT04842240 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2021-04-13

No results posted yet for this study

Summary

The PROM Q study aims to compare patient reported outcome measures (PROMs) in patients undergoing mastectomy and immediate implant based breast reconstruction (IBR). This is the commonest form of breast reconstruction and current advances in surgical technology have led to increasing number of patients having implants placed above the pectoral muscle (pre-pectoral), rather than below it (sub-pectoral). This has important benefits for patients including shorter surgery time, quicker recovery, and avoidance of animation deformity (visible muscle twitching of the reconstructed breast) as the pectoral muscle is not divided to cover the implant. However, potential disadvantages include rippling effect as the implant is covered by the skin and subcutaneous tissue only, as well as potentially higher risk of capsule (scar tissue) formation.

By utilising a validated questionnaire (BREAST-Q), we will assess for any difference in PROMs between the two groups of patients. The results will provide valuable information for future patients when making an informed decision about their reconstruction options. This questionnaire study will include consecutive patients undergoing mastectomy and immediate IBR for breast cancer as well as for risk reduction at Leeds Teaching Hospitals NHS Trust. The study participants will undergo either pre- or sub-pectoral IBR based on their informed discussion with the clinical team. This is a non-randomised observational study.

Conditions

Interventions

PROCEDURE

Pre- or sub-pectoral implant based immediate breast reconstruction

All study participants will undergo skin sparing mastectomy (with or without nipple preservation) for breast cancer or for risk reduction. Patients will undergo immediate breast reconstruction using an implant or a tissue expander. The device will be placed in pre- or sub-pectoral plane which will be supported by mesh (Tiloop/Surgimend Acellular Dermal Matrix) and/or a dermal flap.

Sponsors & Collaborators

  • The Leeds Teaching Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • Baek Kim, FRCS MD MA · Leeds Teaching Hospitals NHS Trust

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2022-12-31
Completion
2022-12-31

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 NCT04842240 on ClinicalTrials.gov