Intraoperative Indocyanine Green Laser Angiography; Postoperative Outcomes for Autologous Tissue Flaps

Study Overview
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Brief Summary
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The purpose of this study is to identify and compare complication rates between autologous breast reconstruction techniques with and without the inclusion on intraoperative indocyanine green (ICG) angiography.

Detailed Description
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ICG-angiography is a real-time visualization of tissue perfusion using intravenous fluorescence. It allows the surgeon a tool for intraoperatively assessment of tissue perfusion of the autologous flap, providing a basis for trimming of hypo perfused areas. The study evaluates the effect of inclusion of this technique by examine postoperative outcomes retrospectively. This is done by differentiation between major and minor complications to evaluate the greatest gains of the intervention.

Official Title
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Intraoperative Indocyanine Green Laser (ICG) Angiography; Evaluation of Postoperative Outcomes for Breast Reconstruction With Autologous Tissue Flaps

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Indocyanine green angiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible patients over the age of 18 years Deemed suitable for breast reconstruction with the latissimus dorsi (LD) myocutaneous flap, muscle sparring LD flap or transverse rectus abdominal muscle (TRAM) flap Exclusion Criteria: Patients with recurrence of breast cancer Smoking 4 weeks prior of operation Not able to read and understand Danish

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention - ICG angiography<br>ICG-angiography was used intraoperatively after placement of the flap at the recipient cite, evaluating the viability and perfusion of the flap. Poor perfused areas were excised | Device: Indocyanine green angiography<br> <br> |
| Control - clinical assessment<br>A control group receiving identical operations but without ICG-angiography evaluation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major complications | Major complications included necrosis of most of the flap (2/3), total flap loss and surgical evacuated hematoma. | Measured at 6 months followup. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minor complications | A minor complication included clinical sign of infection, prolonged wound healing (defined as prolonged healing time requiring dressing changes assisted by health personnel), fat necrosis and skin necrosis. | Measured from day 0 with 6 months followup | 
| Timing of reconstruction | Comparison of the timing of the reconstruction with the complication rate, comparing immediate reconstructions with delayed reconstructions. | Measured from day 0 with 6 months followup | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast reconstruction, Autologous tissue flaps, Indocyanine green angiography, Breast cancer