UnknownNot Applicable

The Effects of Indocyanine Green Angiography (IGA) on Deep Inferior Epigastric Artery Perforator (DIEP) Flap Design and Post-Operative Fat Necrosis

United States100 participantsStarted 2014-01

Plain-language summary

The aim of this study is to prospectively evaluate the effect of intra-operative Indocyanine green angiography (IGA) on both flap design and rate of post-operative fat necrosis in patients undergoing autologous breast reconstruction utilizing the Deep Inferior Epigastric Artery Perforator (DIEP) flap.

Who can participate

Age range

25 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Female patients at the University of Washington
. Aged twenty-five to sixty-five years
. Pursuing immediate or delayed, DIEP-based, autologous, microsurgical breast reconstruction at the University of Washington Medical Center

Exclusion criteria

. Patients unsuitable for autologous, microsurgical breast reconstruction utilizing the DIEP flap - i.e. patients who have undergone prior extensive abdominal surgeries, have inadequate abdominal tissue bulk, who cannot comply with standardized post-operative restrictions / assessments or patients afflicted with a medical condition(s) precluding prolonged general anesthesia and surgery.
. Patients who have a known allergy to contrast media will also be excluded from this study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of post-operative fat necrosis

Timeframe: 3-6 months post-operatively

Trial details

NCT IDNCT02144961

SponsorUniversity of Washington

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-01

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