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

University of Aarhus

Status: Completed

Conditions: Breast Cancer

Treatments: Device: Indocyanine green angiography

Study type: Observational

Funder types: Other

Identifiers

NCT03069261

ICG-angiography

Details and patient eligibility

About

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.

Full 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.

Enrollment: 171 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

171 participants in 2 patient groups

Intervention - ICG angiography

Description:

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

Treatment:

Device: Indocyanine green angiography

Control - clinical assessment

Description:

A control group receiving identical operations but without ICG-angiography evaluation.