NCT03069261

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 3, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

October 26, 2017

Status Verified

February 1, 2017

Enrollment Period

1.1 years

First QC Date

February 27, 2017

Last Update Submit

October 25, 2017

Conditions

Breast Cancer

Keywords

Breast reconstructionAutologous tissue flapsIndocyanine green angiographyBreast cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Minor complications

    Measured from day 0 with 6 months followup

  • Timing of reconstruction

    Measured from day 0 with 6 months followup

Study Arms (2)

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

Device: Indocyanine green angiography

Control - clinical assessment

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

Interventions

Indocyanine green angiographyDEVICE
Intervention - ICG angiography

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent immediate or delayed, pedicle autologous flap breast reconstruction between 2012 and 2016 were enrolled in the study.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2017

First Posted

March 3, 2017

Study Start

August 1, 2016

Primary Completion

August 31, 2017

Study Completion

September 30, 2017

Last Updated

October 26, 2017

Record last verified: 2017-02