Comparing clinical and and quality-of-life outcomes for breast cancer patients undergoing sub-pectoral vs. pre-pectoral implant-based breast reconstruction post mastectomy.

Clinical and and quality-of-life outcomes of pre-pectoral and sub-pectoral breast reconstruction in breast cancer patients: a prospective multi-centre cohort study from Sydney, Australia

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12621000551897

Acronym

PRASE Study

Enrollment

400

Registered

2021-05-11

Start date

2021-05-15

Completion date

2023-05-15

Last updated

2021-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will compare clinical and quality-of-life outcomes for breast cancer patients undergoing sub-pectoral vs. pre-pectoral implant-based breast reconstruction post mastectomy Who is it for? You may be eligible to join this study if you are aged 18 and above, diagnosed with stage 0-III breast cancer and planning to undergo nipple or skin sparing mastectomy with immediate reconstruction (as recommended by your treating breast surgeon). Study details All participants in this study will be asked to provide access to their medical records regarding baseline demographic data (such as age, weight, smoking status) and any medical complications related to their breast reconstruction surgery. They will also be asked to complete a series of short surveys designed to assess quality of life and aesthetic outcomes. The data gathered will be used to compare clinical, quality of life and aesthetic outcomes between a groups of women who have one type (pre-pectoral) of implant-based breast reconstruction to another type (sub-pectoral) implant-based breast reconstruction. Participants will not be required to attend any additional appointments beyond their routine follow-up appointments at three months, one year and two years. The PRASE Study is the first study to compare these two techniques of breast reconstruction in an Australian population. It is hoped that this research will contribute to improving health outcomes for patients with breast cancer.

Interventions

The exposure consists of the patient undergoing the newer method of implant-based breast reconstruction, in which the implant is placed superficial to the pectoralis major muscle. The surgeon and patient will make a joint decision about which type of reconstruction the patient would like to proceed with (the alternative being sub-pectoral reconstruction, the control arm). Participating in the study will not affect this decision, since the study is strictly observational in nature. If patients choose to participate, they will allow researchers to audit their medical records (only those records that relate to baseline demographic data or surgical outcomes/complications). They will also be asked to fill out a number of questionnaires during their scheduled post-operative visits. Participating patients will not be required to attend any follow-up appointments beyond those that would be scheduled if they had chosen not to participate in the study. Filling out these questionnaires will take no more than an extra 30 minutes for each visit. Participants will be followed-up for 2 years post-operatively. Researchers will audit their medical records to assess any complications related to the initial surgery, as well as any signs of cancer recurrence.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

- 18 years old or older - Stage 0 - III breast cancer - Not pregnant - Able to understand the consent process - Nipple or skin sparing mastectomy with immediate reconstruction (expander or implant based)

Exclusion criteria

- Stage IV breast cancer - Immediate autologous reconstruction (with or without implants) - Delayed reconstruction (not including revision of expanders) - Revision surgery (not including revision of expanders)

Outcome results