Partial or double mastectomy with concomitant or subsequent breast reconstruction Concerning a type of surgical operation in which one or both breasts are completely of partly removed and in which the breast is reconstructed during the same operation
Conditions
Interventions
Intra operative use of indocyaninegroen angiografie (ICG) in reconstructive surgery
Sponsors
University of Buenos Aires
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Female adults within the ages of 18 to 75-yearsPatients undergoing the eligible procedures in an elective fashion (see ‘Clincal data’ section for the listed procedures) Patients able to agree and provide verbal and written consent for participation in this study
Exclusion criteria
Exclusion criteria: Patients will be ineligible for entry in this study if any of the following conditions are met Patients outside the eligible age range Patients with a prior history of breast or thoracic surgery, or prior history of radiotherapy Patients actively pregnant or considering pregnancy. Patients with a known or prior history of allergy to iodine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study endpoints: Fluorescent intensity phases of ICG video recorded (defined in px/s), glucose index score (GIS); being the nipple-areolar complex glucose levels (capillary) corrected with serum glucose levels (venous serum). | — |
Secondary
| Measure | Time frame |
|---|---|
| Basic demographics, general and specific comobidities , intra operative information about the ICG administration and information about the surgical site, presence of complications | — |
Countries
Argentina, Guatemala, Italy, Netherlands
Contacts
Public ContactKW Roskamp
Zuyderland
Outcome results
None listed