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

NCT ID: NCT03069261

Last Updated: 2017-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

171 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-01

Study Completion Date

2017-09-30

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.

Conditions

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Breast Cancer

Keywords

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Breast reconstruction Autologous tissue flaps Indocyanine green angiography Breast cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Intervention - ICG 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

Indocyanine green angiography

Intervention Type DEVICE

Control - clinical assessment

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

No interventions assigned to this group

Interventions

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Indocyanine green angiography

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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ICG-angiography

Identifier Type: -

Identifier Source: org_study_id