Breast surgery Surgery
Conditions
Interventions
Current interventions as of 25/03/2024:
Pre surgery:
The patient will be given the applicable modules of the BREAST-Q Reconstruction version 2.0 questionnaire to complete before their surgery takes
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
Female
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 25/03/2024: 1. Signed informed consent form 2. Female aged 18 years old or above 3. Needing bilateral mastectomy for either: 3.1. Bilateral breast cancer, or 3.2. Risk reduction (due to pathological gene mutation or high-risk family history or previous mantle radiotherapy for lymphoma). 4. Undergoing bilateral mastectomy concurrently with immediate breast reconstruction on both sides 5. Undergoing the same type of breast reconstruction on both sides 6. Adequate liver function where bilirubin is =1.5 x ULN 7. Adequate renal function with a serum creatinine = 1.5 x ULN 8. Willing and able to comply with scheduled visits and study procedures for the duration of the study. _____ Previous inclusion criteria: 1. Signed informed consent form 2. Female aged 18 years old or above 3. Bilateral breast cancer 4. Needing bilateral mastectomy for breast cancer or for risk reduction (due to pathological gene mutation or high-risk family history or previous mantle radiotherapy for lymphoma) 5. Undergoing bilateral mastectomy concurrently with immediate breast reconstruction 6. Undergoing the same type of breast reconstruction on both sides 7. Adequate liver function where bilirubin is < = 1.5 x ULN 8. Adequate renal function with a serum creatinine < = 1.5 x ULN 9. Willing and able to comply with scheduled visits and study procedures for the duration of the study.
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 25/03/2024: 1. Locally advanced breast cancer with skin involvement 2. Previous unilateral breast radiotherapy (if mastectomy is for local recurrence) 3. Previous significant unilateral breast surgery (such as reduction) judged by the recruiting/operating surgeon to have adversely affected breast supply on that side 4. Known allergies or hypersensitivity to indocyanine green (ICG) dye, sodium iodide or iodine or having experienced previous side-effects of ICG dye or its components 5. Patients with an overactive thyroid or benign tumours of the thyroid gland 6. Patients with severe renal insufficiency 7. Women who are pregnant, plan to become pregnant, or are lactating during the study period. _____ Previous exclusion criteria: 1. Unilateral breast cancer 2. Undergoing unilateral mastectomy 3. Not undergoing immediate breast reconstruction 4. Locally advanced breast cancer with skin involvement 5. Previous unilateral breast radiotherapy (if mastectomy is for local recurrence) 6. Previous significant unilateral breast surgery (such as reduction) judged by the recruiting/operating surgeon to have adversely affected breast blood supply on that side 7. Known allergies or hypersensitivity to indocyanine green (ICG) dye, sodium iodide or iodine or having experienced previous side-effects of ICG dye or its components 8. Patients with an overactive thyroid or benign tumours of the thyroid gland 9. Patients with severe renal insufficiency 10. Women who are pregnant, plan to become pregnant, or are lactating during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 25/03/2024: The relative difference (%) in blood perfusion between each breast in the same patient. Blood perfusion will be measured at 3 time-points (T1: baseline, T2: mid-point, T3: end) during the mastectomy procedure. The relative difference is defined as the difference, D, of Blood perfusion at T2-T1. The t-test will be applied on the between-breast difference on D. _____ Previous primary outcome measure: Blood perfusion will be measured using the SPY-PHI device (%) at 3 time-points (T1: baseline, T2: mid-point, T3: end). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient hospital re-admission, where applicable; assessed trough a questionnaire to the patient at following time points: Follow up week 1, week 2 and week 4-6 2. Patient hospital stay duration, where applicable; assessed trough a questionnaire to the patient at following time points: Follow up week 1, week 2 and week 4-6 3. Patient re-operation required, where applicable; assessed trough a questionnaire to the patient at time points: Follow up week 1, week 2 and week 4-6 4. Patient-reported post-surgery pain scores assessed on a numerical pain score at the following time points: 18hrs, follow-up week 1, week 2 and week 4-6 5. Incidence, type and severity of surgery related adverse events, where applicable; assessed trough a questionnaire to the patient at following time points: Follow up week 1, week 2 and week 4-6 6. Comparison of patients' pre- and post-surgery outcomes measured in a numerical scale of the BREAST-Q Recon version 2.0 questionnaire (Modules 7, 8, 9 and 14), at follow up week 4-6 | — |
Countries
England, United Kingdom
Outcome results
None listed