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

Completed

• Conditions: Breast Cancer
• Interventions: Device: Indocyanine green angiography

• Registration Number: NCT03069261
• Lead Sponsor: University of Aarhus

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-08-01
• Status Verified: 2017-02
• Study First Submitted: 2017-02-27
• Study First Submitted QC: 2017-03-01
• Study First Posted: 2017-03-03
• Primary Completion: 2017-08-31
• Study Completion: 2017-09-30
• Last Update Submitted: 2017-10-25
• Last Update Posted: 2017-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 171

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

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Exclusion Criteria

• Patients with recurrence of breast cancer
• Smoking 4 weeks prior of operation
• Not able to read and understand Danish

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervention - ICG angiography	Indocyanine green angiography	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

Primary Outcome Measures

Name	Time	Method
Major complications	Measured at 6 months followup.	Major complications included necrosis of most of the flap (2/3), total flap loss and surgical evacuated hematoma.

Secondary Outcome Measures

Name	Time	Method
Timing of reconstruction	Measured from day 0 with 6 months followup	Comparison of the timing of the reconstruction with the complication rate, comparing immediate reconstructions with delayed reconstructions.
Minor complications	Measured from day 0 with 6 months followup	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.